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Cloudbyz eTMF Demo | DIA & Custom Folder Structure with 1-Click! | Archival | Report Subscription
Cloudbyz
/@cloudbyz
Aug 10, 2022
This video provides an in-depth demonstration of the Cloudbyz electronic Trial Master File (eTMF) solution, focusing on its capabilities for streamlining clinical document management, ensuring regulatory compliance, and providing real-time study metrics. The system is presented as a unified platform built on the Salesforce cloud, designed to help eTMF managers, sponsors, and CROs maintain oversight of clinical studies and manage the high volume of essential documents required for regulatory audits. The core value proposition highlighted is the ability to simplify complex tasks like folder creation, metadata entry, document archival, and compliance tracking. The demonstration begins by showcasing the system's intuitive homepage and navigation, emphasizing quick access to core entities like accounts, contacts, clinical studies, and sites. A key feature is the ability to instantly generate the standardized DIA (Drug Information Association) folder structure or utilize a custom structure with a single click, providing flexibility while maintaining organization standards. The system supports granular site access control, allowing administrators to expose specific areas, such as a "holding area" or investigator portal, where sites can upload documents for initial Quality Control (QC) review by the sponsor or CRO team before final placement in the TMF. This workflow is crucial for maintaining TMF quality and completeness. A significant focus of the demo is on reducing manual data entry errors and improving efficiency. The platform allows users to view the document content side-by-side with the metadata entry fields on a single screen, eliminating the need to toggle between windows. This feature is positioned as a direct solution to decreasing the probability of metadata entry mistakes. Furthermore, the system supports defined approval processes, tracks approval history, and maintains a comprehensive metadata audit trail, addressing critical regulatory requirements such as 21 CFR Part 11. For study closure, the system facilitates simple archival by allowing users to select a folder level and download the entire content for export with a few clicks. Finally, the demonstration emphasizes the system’s robust reporting and business intelligence capabilities. The platform provides visual dashboards and metrics that display the "health" of the eTMF at various folder levels. Managers can leverage pre-built reports to identify critical issues, such as documents with missing metadata or documents nearing expiration across all active studies. To ensure proactive compliance, the system offers a report subscription feature, allowing users to set conditions (e.g., weekly delivery) for receiving automated reports detailing expiring documents, thereby ensuring crucial deadlines are met and the TMF remains inspection-ready. Key Takeaways: • **Standardized and Custom Folder Creation:** The eTMF solution supports the instant creation of the industry-standard DIA folder structure or allows for the implementation of custom folder structures, providing necessary flexibility while ensuring adherence to established TMF methodologies. • **Enhanced Data Entry Efficiency and Accuracy:** By enabling side-by-side viewing of the document content and its associated metadata fields, the system significantly reduces the chance of manual data entry errors, which is a common pitfall in TMF management and a risk to data integrity. • **Controlled Site Access via Investigator Portal:** The platform allows for controlled access to specific TMF sections, such as a "holding area," enabling sites to drop documents for initial review by the QC team before they are formally filed, ensuring document quality control prior to inclusion in the official TMF. • **Robust Regulatory Compliance Features:** The system includes essential compliance tools, such as defined document approval processes, detailed approval history tracking, and a comprehensive metadata audit trail, which are vital for meeting GxP and 21 CFR Part 11 requirements during regulatory inspections. • **Real-Time TMF Health Metrics:** Users can access visual dashboards and metrics that provide immediate insight into the health and completeness of the eTMF at the study and folder level, allowing managers to quickly pinpoint areas requiring attention or remediation. • **Simplified Study Archival Process:** At the conclusion of a study, the system facilitates easy archival by providing a function to download the entire folder content at any selected level, streamlining the process of preparing the TMF for long-term storage or transfer. • **Proactive Compliance Reporting via Subscriptions:** The ability to set up automated report subscriptions is a critical feature for proactive compliance, allowing managers to receive scheduled reports (e.g., weekly) detailing documents that are missing metadata or nearing expiration, preventing critical regulatory lapses. • **Salesforce Cloud Foundation:** The Cloudbyz eTMF is built on the Salesforce cloud platform, suggesting potential benefits in terms of scalability, security, and ease of integration with other enterprise systems commonly used in commercial and clinical operations (e.g., Veeva CRM). Tools/Resources Mentioned: * Cloudbyz eTMF (electronic Trial Master File) * Salesforce Cloud Platform Key Concepts: * **eTMF (electronic Trial Master File):** A digital repository for essential clinical trial documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. Maintaining an accurate and complete eTMF is a regulatory requirement. * **DIA Structure (Drug Information Association):** A standardized, widely adopted organizational structure for the TMF, ensuring consistency across different clinical trials and organizations. * **Metadata Audit Trail:** A chronological record of all changes made to the data fields (metadata) associated with a document, crucial for demonstrating data integrity and compliance with regulations like 21 CFR Part 11. * **QC Process (Quality Control):** The procedures implemented to review documents uploaded to the TMF to ensure they are accurate, complete, legible, and appropriately filed before being accepted as final TMF documents.
Veeva: Company Details, Growth, & Culture
VentureFizz
/@Venturefizz
Aug 9, 2022
This video explores Veeva Systems' role as the "operating system for Life Sciences," detailing its company structure, growth, and culture through an interview with Steve Harper, SVP Product Management. Veeva, founded in 2007 and serving 47 of the top 50 pharmaceutical companies, offers a combination of software, implementation services, and data services. The discussion highlights Veeva's dual focus on the commercial side of pharma and extensive work in research and development, including drug development, quality processes, clinical trials, and regulatory compliance. A key cultural aspect is their "two in the box" model, pairing technology experts with industry experts to build highly specific and effective products. The video also delves into Veeva's "Digital Trials Platform," aiming to make clinical trials 25% faster and cheaper by 2025 through digitization, and showcases Boehringer Ingelheim as a customer leveraging Veeva's integrated platform across their development process for significant savings and reduced complexity. Veeva's substantial growth, flexible work environment, and recent transition to a Public Benefit Corporation (PBC) status, emphasizing mission-driven work beyond profit, are also discussed as factors attracting talent and customers. Key Takeaways: * **Veeva as the Life Sciences Operating System:** Veeva positions itself as the foundational software platform for the life sciences industry, serving nearly all major pharmaceutical companies with a comprehensive suite of software, services, and data solutions across both commercial and R&D operations. * **Strategic "Two in the Box" Model:** Veeva's core product development and cultural strategy involves pairing technology experts with industry experts. * **Focus on Clinical Trial Digitization:** A major initiative is the "Digital Trials Platform," designed to significantly enhance the efficiency and cost-effectiveness of clinical trials by removing paper-based processes and improving data flow between all participants, aiming for a 25% improvement in speed and cost by 2025. * **Integrated Platform Adoption:** Customers like Boehringer Ingelheim are adopting an "all-in" strategy with Veeva, using its integrated products across their entire development process (clinical, regulatory, quality). This demonstrates the value of a unified platform for reducing complexity and automating data flowai to assist clients with integration and optimization. * **Stability and Mission-Driven Growth:** Veeva exhibits strong growth and stability within the life sciences sector, contrasting with broader tech industry slowdowns. Its conversion to a Public Benefit Corporation (PBC) underscores a commitment to employees, customers, and the community, aligning with a growing industry demand for ethical and impactful technology solutions.
How CBD Works - CORGANICS - CEO - Chad Collins
Self-Funded
@SelfFunded
Aug 9, 2022
This video provides an in-depth exploration of clinical cannabinoid therapy, focusing on the company CORGANICS and its CEO, Chad Collins. The discussion centers on the burgeoning CBD market, the critical need for quality and transparency in a largely unregulated retail space, and CORGANICS' unique approach to bridging the gap between healthcare professionals and patients. Collins, drawing from his extensive background in the pharmaceutical industry, emphasizes the importance of clinical-grade products, rigorous testing, and physician education to ensure patient safety and therapeutic efficacy. The conversation delves into the evolution of the CBD market, noting a significant public interest in CBD as a valid medical therapy, often ahead of healthcare professionals' understanding. Collins highlights the challenges posed by the "wild west" of retail CBD, where products often lack quality control, transparency, and may contain harmful contaminants or undeclared THC. CORGANICS addresses this by exclusively distributing through healthcare channels, ensuring their products are manufactured in FDA-registered facilities, adhere to cGMP standards, and are certified for sport (NSF Safe for Sport) to guarantee THC-free formulations. This stringent quality assurance is crucial for patients, especially those in professions with drug testing requirements like athletes, first responders, and pilots. A significant portion of the discussion focuses on the clinical validation of CORGANICS' products. Collins details IRB-approved studies conducted with over 500 patients through institutions like UCLA, Johns Hopkins, and the University of Washington. These studies specifically targeted common self-treatment reasons for CBD use: pain, sleep, and anxiety. The results demonstrated substantial improvements across these modalities, alongside a notable increase in overall well-being, with a benign side effect profile. This scientific backing differentiates CORGANICS from most retail CBD brands and provides healthcare professionals with the confidence to recommend their products, aligning with a "step therapy" approach where patients seek natural alternatives before resorting to traditional pharmaceuticals like opioids or anxiolytics. The video also explores the scalability and integration of clinical CBD into broader healthcare ecosystems, particularly for employer groups and large medical organizations. Collins discusses how CORGANICS' model allows for access through health and wellness benefit plans, either via direct purchase from practices or through a vetted employer code on their website, enabling direct-to-patient shipping. This approach aims to address high drug utilization costs for employers (e.g., opioids, sedatives) and improve employee productivity by offering a safe, effective, and often less expensive alternative. The CEO also touches upon the future "education revolution" around the endocannabinoid system (ECS), predicting that pharmaceutical companies will eventually drive widespread awareness and acceptance of cannabinoid therapy. Key Takeaways: * **Growing CBD Market & Patient Demand:** A 2019 Gallup poll showed one in five American adults taking CBD, and three in five viewed it as valid medical therapy. This indicates a significant existing market and patient desire for cannabinoid-based solutions, often preceding physician recommendations. * **Quality and Safety Concerns in Retail CBD:** The retail CBD market is largely unregulated, leading to issues with product quality, transparency, and potential contamination (heavy metals, pesticides) or mislabeling regarding THC content. A Leaf Report audit found 21% of tested products claiming no THC actually contained it. * **Importance of Clinical-Grade Products:** CORGANICS, with its pharma-industry background, emphasizes manufacturing in FDA-registered and regulated facilities, adhering to cGMP (Current Good Manufacturing Practices), and achieving NSF Safe for Sport certification to ensure product purity and absence of detectable THC. * **Exclusive Healthcare Distribution Model:** CORGANICS distributes its products solely through healthcare professionals and organizations, not retail or Amazon. This model supports physician education, provides patient access to vetted products, and builds confidence in recommendations. * **Clinical Validation through IRB-Approved Studies:** CORGANICS has invested in robust, independent, IRB-approved studies (e.g., with UCLA, Johns Hopkins, University of Washington) involving over 500 patients. These studies validate the efficacy of their products for pain, sleep, and anxiety. * **Demonstrated Efficacy:** Studies showed significant improvements: 64% in pain, 53% in sleep, 63% in anxiety, and 66% in overall well-being over a month, with a benign side effect profile. This data provides concrete evidence for healthcare professionals and patients. * **Addressing Drug Testing Concerns:** For professional athletes, first responders, pilots, and other individuals subject to drug testing, the guarantee of THC-free products (verified by third-party testing and certifications like NSF Safe for Sport) is paramount to avoid career jeopardization. * **Role of the Endocannabinoid System (ECS):** Healthcare professionals are increasingly learning about the ECS and how cannabinoid therapy interacts with CB1 and CB2 receptor sites throughout the body to help achieve balance and address various disease states. * **Opportunity for Employer Health Plans:** Clinical CBD offers a potential alternative to costly prescriptions (opioids, anxiolytics, sedatives) for employers, improving employee productivity and well-being. Employers can provide access through wellness benefit plans, with patients purchasing at a discount or with employer subsidy. * **Flexible Access for Patients:** Patients can access CORGANICS products either directly through healthcare practices that stock inventory or via a vetted code on the CORGANICS website, allowing for direct-to-patient shipping, ensuring convenience while maintaining healthcare oversight. * **Caution Against Unsubstantiated Claims:** The FDA prohibits making specific health claims for CBD products unless they are approved as prescription drugs. Consumers should be wary of retail brands making exaggerated or unproven claims. * **Benign Side Effect Profile:** High-quality, THC-free cannabinoid therapy is generally considered benign, with no reported overdosing and minimal to no side effects like grogginess, especially when products are rigorously tested. Key Concepts: * **Clinical Cannabinoid Therapy:** The use of cannabinoids, including CBD and minor cannabinoids, for therapeutic purposes, emphasizing a scientific, evidence-based, and quality-controlled approach, often under the guidance of healthcare professionals. * **Endocannabinoid System (ECS):** A complex cell-signaling system in the human body that plays a crucial role in regulating a wide range of functions and processes, including sleep, mood, appetite, memory, and pain sensation. It consists of endocannabinoids, receptors (CB1 and CB2), and enzymes. * **IRB-Approved Studies:** Research studies that have been reviewed and approved by an Institutional Review Board (IRB) to ensure ethical conduct, protection of human subjects, and scientific rigor. This signifies a high standard of clinical validation. * **cGMP (Current Good Manufacturing Practices):** A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. * **NSF Safe for Sport:** A certification program that ensures products are free of banned substances, contaminants, and are accurately labeled. This is particularly important for athletes and others subject to drug testing. * **Detectable THC:** Even trace amounts of THC (tetrahydrocannabinol), the psychoactive compound in cannabis, that can be detected in drug tests, potentially leading to adverse consequences for individuals in certain professions. Examples/Case Studies: * **Gallup Poll (2019):** Highlighted that 1 in 5 American adults used CBD, and 3 in 5 considered it a valid medical therapy, demonstrating significant public interest. * **Leaf Report Audit:** A third-party audit of ~3,000 retail CBD products found that 21% of products claiming to be THC-free actually contained detectable THC, underscoring the lack of quality control in the retail market. * **Largest Oncology Group Partnership:** CORGANICS is partnering with the largest oncology group in the U.S. to provide their exclusive clinical CBD, indicating a growing acceptance and demand for high-quality cannabinoid therapy within specialized medical fields. * **UCLA, Johns Hopkins, University of Washington Studies:** CORGANICS conducted IRB-approved studies with over 500 patients at these institutions, demonstrating 64% improvement in pain, 53% in sleep, 63% in anxiety, and 66% in overall well-being.
Health Literacy and Its Role in Financial Literacy
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Aug 7, 2022
This video provides an in-depth exploration of health literacy, which the speaker, Dr. Eric Bricker, reframes as "patient skill." He argues that just as individuals possess various life skills like budgeting or navigating public transportation, being a patient also requires a distinct set of skills to effectively engage with the healthcare system. The official definition of health literacy, as cited from government sources, is the capacity to obtain, process, and understand health information to make appropriate health decisions. Dr. Bricker emphasizes that patients exhibit varying levels of this skill, impacting their ability to make effective choices for their own health. The presentation details several factors associated with low health literacy, identifying it as a national problem in America. These factors include poverty, lack of a high school degree, having Medicare or Medicaid insurance (versus private commercial insurance), being male, being over 65 years old, and English as a second language. The video then outlines the significant negative consequences of low health literacy, supported by findings from a meta-analysis of 81 studies. These consequences include higher rates of hospitalization and emergency room utilization, lower rates of preventative screenings like mammograms, decreased flu shot rates, and critically, lower medication adherence. Dr. Bricker then shifts to discussing interventions to improve health literacy, categorizing them into three levels: clinician-patient, system-patient, and community-patient interactions. For clinician-patient interactions, he advises healthcare professionals to avoid jargon, explain medical terms clearly, and speak more slowly to allow patients to absorb information. At the system and community levels, effective education needs to be clear, utilize visual aids (especially human faces, as brains are hardwired to respond to them), and be delivered in a shame-free, non-judgmental manner, akin to coaching to improve a skill. He extends this concept to "financial health literacy," highlighting the need for patients to understand complex financial aspects of healthcare such as deductibles, coinsurance, Explanation of Benefits (EOBs), and prior authorizations. He cites the Allen Health Academy's 16-video curriculum as an example of effective financial health literacy education that employers can integrate into wellness programs, concluding with a math analogy to illustrate that providing data (like biometrics or EOBs) without teaching the "equation" (literacy) to interpret it renders the data useless for decision-making. Key Takeaways: * **Health Literacy as "Patient Skill":** Health literacy is not merely an academic concept but a practical "patient skill" that varies among individuals and significantly impacts their ability to make informed health decisions. This reframing helps to de-stigmatize the issue and focus on skill improvement. * **Socioeconomic and Demographic Determinants:** Low health literacy is strongly correlated with factors such as poverty, lower educational attainment, specific insurance types (Medicare/Medicaid), older age, being male, and English as a second language, highlighting systemic challenges. * **Significant Negative Health Outcomes:** A meta-analysis of 81 studies confirms that low health literacy leads to tangible adverse outcomes, including increased hospitalizations, higher ER visits, reduced preventative screenings (e.g., mammograms), lower vaccination rates (e.g., flu shots), and decreased medication adherence. * **Multi-Level Intervention Strategies:** Improving health literacy requires a multi-pronged approach involving interventions at the clinician-patient level (e.g., clear communication, slower speech, no jargon), system level (e.g., hospital systems, insurance, employers), and community level. * **Principles of Effective Health Education:** Education designed to improve health literacy should be clear, utilize engaging visual aids (especially human faces to leverage natural brain responses), and be delivered in a shame-free, non-judgmental coaching style to foster skill development rather than imply deficiency. * **Superiority of Video for Education:** Video is presented as a highly effective medium for delivering health information due to its visual and auditory nature, making it more engaging and easier to absorb than written materials, especially in the context of modern smartphone and internet access. * **Criticality of Financial Health Literacy:** Beyond clinical information, understanding the financial aspects of healthcare (deductibles, co-insurance, EOBs, prior authorizations) is a crucial component of overall health literacy, enabling patients to navigate costs and make sound financial decisions related to their care. * **Actionable Data Requires Literacy:** Providing individuals with health-related data (e.g., biometrics, EOBs) without also equipping them with the "equation" or literacy to understand and act upon that data is ineffective, akin to giving someone an algebraic equation without teaching them how to solve it. * **Corporate Wellness Program Integration:** Employers should consider integrating financial health literacy education into corporate wellness programs, as current assumptions that employees understand complex healthcare financial data are often incorrect. * **The Allen Health Academy Model:** The Allen Health Academy's 16-video curriculum on financial health literacy is highlighted as a practical example of a system-level educational resource that employers can leverage to improve their health plan members' understanding. * **Medication Adherence Impact:** The direct link between low health literacy and lower medication adherence is a critical insight for pharmaceutical companies, suggesting that improving patient understanding can lead to better treatment outcomes and commercial success. Tools/Resources Mentioned: * **Allen Health Academy:** A 16-video curriculum focused on financial health literacy, recommended for employers to use with health plan members. * **Video as an Educational Medium:** Emphasized as a highly effective way to provide clear, engaging information compared to written materials. Key Concepts: * **Health Literacy:** The capacity to obtain, process, and understand health information to make appropriate health decisions. * **Patient Skill:** An alternative, less "wonky" term for health literacy, emphasizing that it is a learnable ability. * **Financial Health Literacy:** The specific skill set required to understand and navigate the financial aspects of healthcare, including insurance terms, bills, and costs. * **Clinician-Patient Interaction:** The direct communication between healthcare providers and patients. * **System-Patient Interaction:** How healthcare systems (hospitals, insurers, employers) communicate with and educate patients. * **Community-Patient Interaction:** Broader educational efforts within communities to improve health understanding. Examples/Case Studies: * **Marshall Allen:** A former ProPublica healthcare journalist and professor who founded the Allen Health Academy. * **Compass:** A company that helped over 1.8 million people navigate health insurance and healthcare over 11 years, encountering many with low financial health literacy. * **Math Analogy (y=mx+b):** Used to illustrate that providing data (m and b) without teaching the method to interpret it (how to draw the line) makes the data useless.
The Modern TPA - HealthSmart - Tech & People - Craig Julien
Self-Funded
@SelfFunded
Aug 2, 2022
This interview features Craig Julien, CEO of HealthSmart, a Third Party Administrator (TPA), providing an in-depth look at the evolving role of TPAs in the self-funded health plan market. The discussion establishes the TPA as the administrative partner for self-funded employers, handling all functions typically managed by a fully insured carrier, including claims adjudication, EOBs, member services, care management, and PBM services. A central theme is the modernization of the TPA model, encapsulated by HealthSmart’s philosophy: "Technology when you need it, people when you don't," emphasizing the balance between digital efficiency and essential human empathy in healthcare interactions. Julien details the infusion of technology into TPA operations, distinguishing between visible and invisible tech. Invisible technology includes core systems for digitizing manual processes like claims and correspondence, focusing on interoperability and data transportability via APIs and open source standards. Visible technology includes member portals, mobile apps, and advanced phone systems designed to guide members to the fastest, highest-quality answers. This technological push is driven partly by regulatory mandates like the No Surprises Act and Transparency in Coverage, which require TPAs to implement price transparency tools, allowing members to "shop" for services by running mock claim adjudications based on procedure codes and benefits before receiving care. The conversation also explores major industry trends and operational strategies. HealthSmart is actively moving down-market with a level-funded hybrid option called "Smart Care," targeting employers in the 1-100 employee range who desire the control of self-funding without bearing excessive financial risk. Furthermore, Julien highlights the increasing importance of data integration, noting the use of platforms like Deer Walk to identify "trigger diagnosis codes" that signal high future healthcare costs. This data is used to proactively invoke care management discussions, particularly concerning specialty drugs, where in-house PharmDs engage providers to potentially adjust drug use or frequency to control costs while maintaining quality of care. Finally, the discussion touches on behavioral economics, exploring how to incentivize members (through rewards or benefit design) to utilize lower-cost, high-quality care options like virtual care (e.g., Teledoc, virtual MSK) and direct primary care, shifting member interaction from reactive "push" to proactive "pull" engagement. ## Detailed Key Takeaways * **Data-Driven Care Management and Rx Optimization:** TPAs leverage data platforms (like Deer Walk) to identify "trigger diagnosis codes" that predict high future costs. This data is critical for proactive intervention by care management teams, including in-house Registered Nurses and PharmDs, particularly for managing specialty drug utilization and costs. * **The Modern TPA Philosophy:** The operational model must balance digital efficiency with human empathy, summarized as "Technology when you need it, people when you don't." This ensures that while routine tasks are automated, complex or emotionally sensitive issues are handled by knowledgeable staff who provide education and decision support. * **Regulatory Impact on Technology:** Compliance drivers such as the No Surprises Act and Transparency in Coverage are mandating the development of new technology, specifically tools that enable members to receive accurate, point-in-time cost estimates for medical services before they are rendered. * **Interoperability and Data Flow:** Modern TPA systems rely heavily on APIs and open-source standards to ensure data transportability and interoperability between core claims processing systems, PBMs, stop-loss carriers, and external care management vendors. * **Shifting Member Behavior through Incentivization:** To increase the adoption of lower-cost, high-quality options like virtual care (e.g., Teledoc), TPAs must implement incentivization models (e.g., small rewards for creating an account) to overcome initial behavioral barriers and make the convenient option the default choice. * **Addressing Down-Market Needs:** The small employer market (1-100 employees) is addressable by offering level-funded hybrid options (like Smart Care), which provide the data control and benefit flexibility of self-funding while stabilizing premiums and mitigating financial risk. * **Behavioral Economics in Healthcare:** Understanding that patient decisions are often driven by "hope" (seeking experimental care) or "reassurance" (over-consuming unnecessary tests) is crucial for designing benefits and communication strategies that guide conscientious decision-making. * **Preventing Denial of Care Events:** A critical operational focus is minimizing "denial of care events" caused by administrative failures (e.g., eligibility file errors), which immediately erode member trust and can lead to catastrophic financial outcomes for the patient. * **The Rise of Retail and Virtual Care:** The trend toward retail and virtual healthcare delivery (including virtual MSK and expanded mental health services) requires TPAs to integrate these options seamlessly and ensure members are aware of and utilize them appropriately to manage costs and convenience. * **Proactive Member Engagement (Pull vs. Push):** Instead of constantly pushing information, TPAs should aim to build trust early (e.g., during enrollment by verifying in-network providers) so that members proactively "pull" information and guidance from the TPA when a need arises. * **Integrated In-House Model:** Having an integrated model where core systems, technology, and clinical staff (nurses, PharmDs) are connected allows for faster, more informed decision-making and a unified member experience, avoiding the friction of siloed vendors. * **Aligning Incentives:** The broader healthcare trend involves aligning incentives between payers and providers (seen in large entities buying into the supply chain of care delivery) to control costs and improve quality holistically. ## Tools/Resources Mentioned * **Deer Walk:** Industry-standard data platform used for data analysis, identifying trigger diagnosis codes, and informing care management strategies. * **Teledoc:** A virtual care partner utilized by HealthSmart, representing the growing trend of virtual health services. * **Smart Care:** HealthSmart’s proprietary level-funded health plan option targeting the small-to-mid market (1-100 employees). ## Key Concepts * **Third Party Administrator (TPA):** An organization that performs administrative services (claims processing, member services, data management) for self-funded health plans. * **Level-Funded Option:** A hybrid insurance model where premiums are fixed and level, blending elements of fully insured and self-funded plans to stabilize costs for smaller employers. * **Price Transparency in Coverage:** Regulatory mandates requiring healthcare entities to provide clear cost information to consumers upfront, enabling them to shop for services. * **Behavioral Economics:** The field of study focused on the psychological factors influencing economic decisions, used in healthcare to design incentives and communication strategies that guide members toward better health choices. * **Trigger Diagnosis Codes:** Specific medical codes that signal a diagnosis likely to lead to high future healthcare utilization and cost, prompting proactive care management intervention. * **No Surprises Act:** Legislation aimed at protecting consumers from unexpected medical bills, particularly those resulting from out-of-network services provided during an in-network visit.
Hospitals Measure Doctors By How Much Revenue They Generate
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 31, 2022
This video provides an in-depth exploration of how hospitals financially evaluate physicians, focusing on the revenue doctors generate rather than patient outcomes. Dr. Eric Bricker, from AHealthcareZ, begins by presenting data from a 2016 Merritt Hawkins survey of hospital CFOs, revealing that the average physician drives $1.56 million in hospital revenue annually through tests, procedures, and orders. This establishes a core theme: hospitals, operating within a fee-for-service system, are highly attuned to physicians as revenue drivers, a metric that often overshadows quality-of-care indicators. The presentation delves into the specifics of revenue generation across different medical specialties. Orthopedic surgeons were found to be the highest revenue generators, bringing in $2.75 million per year, followed by interventional cardiologists ($2.45 million) and general surgeons ($2.17 million). Even family practice doctors, who primarily operate in outpatient settings, contribute significantly, generating $1.5 million annually, largely through ordering outpatient labs and imaging that flow to the hospital system. Dr. Bricker highlights how hospitals strategically employ primary care physicians to capture this revenue, demonstrating a calculated business approach where physician salaries are an investment to secure a larger revenue stream. Further analysis in the video compares physician salaries to the revenue they generate, framing it as a "commission" or return on investment (ROI). For instance, orthopedic surgeons, paid an average starting salary of $500,000, yield a net revenue of $2.25 million for the hospital, representing an 18% "commission." Family practice doctors, with a $198,000 starting salary, net $1.3 million, equating to a 13% "commission" but a higher ROI of 7.5x compared to 5.5x for orthopedists. This favorable ROI explains why family practice and internal medicine physicians have consistently been the most sought-after recruits for hospitals. Dr. Bricker critically observes that hospital CEOs and CFOs are acutely aware of these revenue metrics, often recalling them offhand, while rarely discussing patient quality metrics like infection rates or readmission rates, underscoring a systemic prioritization of financial gain over patient well-being. However, the video concludes with a hopeful counter-narrative, showcasing examples of hospitals that are actively shifting their focus from revenue to patient-centric quality metrics. University Hospitals in Cleveland, under the leadership of Dr. Peter Pronovost (Chief Clinical Transformation Officer), is presented as a prime example. This institution won a major award for quality transformation from the American Hospital Association, demonstrating an 80% reduction in central line-associated bloodstream infections and a 33% decrease in Medicare costs through quality initiatives. This case study illustrates that by measuring and managing patient-centric values, hospitals can dramatically improve quality and even reduce costs, challenging the notion that high revenue must come at the expense of patient care. Dr. Pronovost's quote, "hospitals are filled with mismanagement," is used to emphasize that a revenue-first approach can lead to systemic inefficiencies and suboptimal patient outcomes. Key Takeaways: * **Physicians as Hospital Revenue Drivers:** Hospitals view physicians as significant revenue generators, with an average doctor bringing in $1.56 million annually through ordered tests, procedures, and referrals, highlighting the financial engine of the fee-for-service model. * **Specialty-Specific Revenue Impact:** Revenue generation varies significantly by specialty; orthopedic surgeons are the highest contributors ($2.75M/year), followed by interventional cardiologists ($2.45M/year), and general surgeons ($2.17M/year). * **Outpatient Revenue Contribution:** Even primary care physicians, predominantly working in outpatient settings, drive substantial hospital revenue ($1.5M/year) by ordering outpatient labs and imaging, which are often processed by hospital systems. * **Strategic Physician Employment:** Hospitals strategically employ primary care physicians to consolidate revenue streams. By acquiring independent practices, hospitals can capture the entirety of a physician's generated revenue rather than just a portion. * **Physician Compensation as Investment:** Physician salaries are viewed by hospitals as an investment to secure larger revenue streams, with the "commission" (salary as a percentage of revenue) varying by specialty. * **Return on Investment (ROI) for Physicians:** Family practice physicians offer a higher ROI (7.5x) for hospitals compared to orthopedic surgeons (5.5x), making them highly sought after for recruitment due to their favorable financial leverage. * **Revenue-Centric Management:** Hospital CFOs and CEOs are acutely aware of revenue-per-doctor metrics, often prioritizing these financial figures over patient quality indicators like infection rates, readmission rates, or post-operative complication rates. * **Fee-for-Service System's Intent:** The current fee-for-service healthcare system is described as a "well-oiled machine" intentionally designed to maximize healthcare spending and revenue generation, rather than focusing on cost containment or patient outcomes. * **Misplaced Prioritization:** The emphasis on revenue metrics can lead to "mismanagement" within hospitals, diverting focus away from patient well-being and quality of care. * **Hope for Quality Transformation:** There is a growing movement towards changing hospital metrics to prioritize patient quality and outcomes over revenue, demonstrating that improved quality can also lead to reduced costs. * **Case Study: University Hospitals Cleveland:** This institution successfully reduced central line-associated bloodstream infections by 80% and Medicare costs by 33% through quality initiatives, proving that patient-centric metrics can drive significant improvements in care and financial efficiency. * **Impact of Measuring Quality:** When hospitals measure patient-centric, quality-focused values, it leads to dramatic improvements in management, patient safety, and overall healthcare delivery, challenging the traditional revenue-driven model. Examples/Case Studies: * **Merritt Hawkins Survey:** A 2016 survey of hospital CFOs by physician recruiting firm Merritt Hawkins provided the core data on physician revenue generation. * **University Hospitals in Cleveland:** Featured as an example of a hospital system that successfully shifted its focus to quality, achieving an 80% reduction in central line-associated bloodstream infections and a 33% decrease in Medicare costs. * **Dr. Peter Pronovost:** Chief Clinical Transformation Officer at University Hospitals in Cleveland, recognized for his work in making hospitals safer and more patient-focused.
Meet our Practice Leaders | Join Veeva R&D Services Europe
Veeva Systems Inc
/@VeevaSystems
Jul 31, 2022
This video, featuring practice leaders from Veeva R&D Services Europe, offers an internal perspective on the company’s culture, operational philosophy, and approach to innovation within the life sciences technology sector. The primary purpose of the discussion is to articulate the unique value proposition of working at Veeva, emphasizing a fast-paced, customer-centric, and intellectually challenging environment. The leaders stress that Veeva is fundamentally a "different company," driven by a commitment to rapid product evolution and deep customer partnership, which allows them to bring significant innovation to the pharmaceutical and biotech industries. A central theme explored is the symbiotic relationship between Veeva and its customers. The practice leaders highlight that innovation is driven not just by internal development, but by building "trusted relationships" to truly understand customer challenges. This understanding is then used to directly inform and drive product development, ensuring customers receive solutions for what they are "really asking for." Furthermore, Veeva aims not only to meet customer needs but also to "reshape the customer's perspectives" on how processes can be executed, helping them "break new ground" and change operating models. This proactive stance positions Veeva as a strategic partner, not just a software vendor, particularly as customers in the industry are increasingly seeking to innovate and accelerate their pace of change. The discussion also heavily emphasizes the operational intensity and learning culture required to succeed within the organization. A critical operational detail mentioned is the speed at which Veeva’s products evolve, changing three times per year. This rapid release cycle necessitates a culture of constant learning, ensuring employees are always mastering new functionalities and innovations. The leaders stress the importance of critical thinking, taking responsibility, and pushing boundaries as core work ethics. They foster an environment where making mistakes is accepted as long as the organization learns from them, promoting continuous improvement and resilience. This intense focus on execution, speed, and continuous professional growth is presented as the engine driving both internal development and customer success. Key Takeaways: • **Rapid Product Evolution Requires Consulting Agility:** Veeva products undergo significant changes and updates three times per year, demanding that consulting partners maintain an extremely high pace of internal learning and certification to effectively implement, integrate, and customize solutions for clients. • **Innovation is Customer-Driven:** Veeva’s product roadmap is heavily influenced by deep, trusted relationships with customers, using direct feedback on operational challenges to drive innovation, suggesting that consulting firms should focus on translating client pain points into actionable feature requests or integration needs. • **Strategic Partnership Focus:** Veeva aims to be more than a vendor; its goal is to "reshape the customer's perspectives" and help them "break new ground," indicating that successful consulting engagements must involve strategic change management and process optimization, not just technical implementation. • **High Pace of Internal Operations:** The company maintains a "really fast" internal pace, requiring consultants working with Veeva platforms to match this intensity, focusing on execution, critical thinking, and pushing boundaries to deliver timely results. • **Value of Integrity and Leadership:** Practice leaders emphasize the importance of acting with integrity, being bold and honest, and leading the customer, suggesting that successful engagements require consultants to confidently guide clients toward optimal, compliant solutions. • **Learning Culture is Mandatory:** Due to the constant introduction of new functionalities and innovations, continuous learning is not optional; consulting teams must proactively dedicate resources to mastering new Veeva releases immediately upon deployment. • **Embracing Failure for Growth:** The culture encourages making mistakes as long as the organization learns from them, highlighting the importance of post-mortems and iterative improvement cycles in complex software development and implementation projects. • **Focus on Execution and Intensity:** Success within the Veeva ecosystem requires putting in significant effort, working with intensity, staying focused, and prioritizing execution, which is a key expectation for any partner firm engaging in complex system integrations. • **Challenging the Status Quo:** Veeva actively helps customers change the way they are operating and innovate, confirming that the life sciences industry is currently undergoing a significant shift toward digital transformation and requiring external expertise to facilitate this change. Key Concepts: * **Customer-Led Innovation:** The methodology of using deep customer relationships and direct feedback loops to inform and accelerate product development cycles. * **Perspective Reshaping:** Veeva’s strategic goal of not just providing software but influencing and changing the customer's traditional operating models and views on what is technologically possible. * **Three-Times-a-Year Release Cycle:** A specific operational detail indicating the high frequency of product updates and the resulting requirement for continuous professional development among users and consulting partners.
Meet our Team | Join Veeva R&D Services Europe
Veeva Systems Inc
/@VeevaSystems
Jul 31, 2022
This video provides an internal perspective on the culture, mission, and operational philosophy of Veeva R&D Services in Europe, serving primarily as a recruitment tool but offering significant insights into the consulting model within the life sciences technology space. The core message emphasizes that success in implementing Veeva solutions requires a deep integration of industry knowledge, technical expertise, and consulting skills, creating a "continuous learning experience" for employees. Veeva actively seeks to hire professionals from diverse backgrounds—including industry veterans, tech specialists, and management consultants—to form a "melting pot of diverse perspective and experience" necessary for tackling the complex challenges faced by pharmaceutical and biotech clients. A central theme is the necessity of understanding the customer's world to deliver meaningful impact. Team members stress that learning about the life sciences industry is paramount, as it allows them to truly comprehend customer needs and provide tailored solutions. This customer-centric approach is directly tied to the ultimate mission of the industry: "making patients lives better." Consultants view their role as strategic partners who provide expert advice and lead customers to the optimal solution, thereby achieving "real business impact" rather than simply executing technical tasks. This advisory positioning underscores the high-value nature of Veeva's professional services in the R&D sector. The operational environment is characterized by constant challenge and high collaboration. Internally, Veeva fosters an environment where consultants can leverage collective organizational knowledge globally, reaching out to colleagues across Europe, North America, and Asia to share experiences and solve similar technical or business issues. Externally, the work demands exceptional critical thinking and curiosity because "no two customers are the same," ensuring that consultants are continually faced with new, complex problems. These challenges range from mastering new Veeva products and technologies to learning intricate pharmaceutical business processes and building strong relationships in remote or hybrid settings. The company positions itself as "disruptive," implying that its services involve significant transformation of client processes, requiring dedicated professionals who find fulfillment in tackling difficult, industry-specific problems. Key Takeaways: • Veeva R&D Services prioritizes a multidisciplinary hiring strategy, actively blending talent from core industry roles, technology development, and traditional consulting to ensure their teams possess the comprehensive knowledge required for complex life sciences implementations. • The consulting model is highly advisory, focusing on guiding customers toward the best strategic solution for their business objectives, positioning Veeva as a partner driving "real business impact" rather than just a software implementer. • Success in the Veeva ecosystem requires consultants to be critical thinkers and curious learners, as the nature of R&D operations means every customer engagement presents unique regulatory, technical, and process-related challenges. • Veeva maintains a robust global collaboration framework, enabling consultants to quickly access and draw upon the collective experience of teams across different continents (Europe, North America, Asia) to troubleshoot and solve complex customer issues efficiently. • The company explicitly ties its consulting work to the life sciences mission of "making patients lives better," providing a strong motivational framework that aligns service delivery with high-level client and societal goals. • Consultants are expected to manage continuous professional challenges, including rapid assimilation of new Veeva products, mastering evolving regulatory business processes, and effectively building meaningful client relationships in remote or hybrid work environments. • The focus on being "disruptive" indicates that Veeva R&D Services engagements often involve significant organizational change management and process transformation within highly regulated client environments. • The ability to operate effectively across diverse European locations (e.g., Copenhagen, Barcelona) confirms that Veeva utilizes a mature, high-impact remote service delivery model, maintaining consistent quality regardless of the consultant's physical location. • The emphasis on accumulating diverse perspectives into a "melting pot" suggests that the most complex Veeva implementations require multidisciplinary teams to successfully navigate the intersection of GxP compliance, data engineering, and commercial operations. Key Concepts: * **Veeva R&D Services:** The professional services arm of Veeva Systems focused on implementing and optimizing solutions related to clinical, regulatory, quality, and safety operations within the life sciences industry. * **Continuous Learning Experience:** The cultural expectation that employees must constantly update their knowledge regarding new technologies, Veeva products, and evolving life sciences business processes. * **Disruptive:** A self-description indicating that the services provided lead to significant, transformative changes in how pharmaceutical and biotech companies manage their R&D operations, often involving the replacement of legacy systems and processes.
Top 5 Stocks to BUY NOW Part 2 (High Growth Stocks)!
YT Finance
/@ytfinance
Jul 28, 2022
This video, part of a series on top growth stocks, provides an investment analysis of Palantir Technologies, Upstart, and Veeva Systems. While Palantir and Upstart are discussed for their general AI and data analytics capabilities in government/commercial and financial lending sectors respectively, a significant portion of the video is dedicated to Veeva Systems. The speaker highlights Veeva's crucial role as a cloud-based software provider for the pharmaceutical and life sciences industries, emphasizing its use by 18 out of the top 20 pharmaceutical companies. The video positions Veeva as a "defensive" and "recession-proof" stock due to the indispensable nature of its software, which optimizes clinical data management, various operations, regulatory compliance, and customer data analytics within the life sciences sector. Key Takeaways: * **Veeva's Pervasive and Critical Role in Pharma:** The video strongly affirms Veeva Systems as an essential technology partner for the pharmaceutical industry, with its software being "imperative and critical" for daily operations and used by nearly all top pharma companies. * **Stability and Growth in Life Sciences Tech:** The characterization of Veeva as a "recession-proof" company with sustainable demand underscores the inherent stability and growth potential within the life sciences technology sector, particularly for solutions that support critical business functions.
Jim Reilly | 2022 Veeva R&D and Quality Summit | Register Now
Veeva Systems Inc
/@VeevaSystems
Jul 27, 2022
This video serves as a promotional invitation for the 2022 Veeva R&D and Quality Summit, highlighting the event’s return to an in-person format in Boston. The speaker, Jim Reilly, emphasizes the significance of the summit as a premier cross-industry gathering designed to connect thousands of peers, leaders, and experts across critical functions within the life sciences sector. The primary goal of the summit is to foster collaboration and idea sharing on how to advance the life sciences industry through technology and process innovation, underscoring the value of face-to-face interaction for building relationships and sharing insights. The summit is positioned as a crucial meeting point for professionals working in clinical, quality and manufacturing, regulatory, safety, and IT departments. A major theme for the event is "Better Trials for All Through a Connected Clinical Ecosystem," signaling a strategic industry shift toward integrated technological platforms and streamlined processes in clinical development. This focus on connectivity aims to address challenges and drive better engagement from the perspectives of sponsors, investigative sites, and patients, recognizing that optimizing the trial experience requires holistic system integration. To maximize interaction and knowledge exchange, the 2022 summit introduced several format changes. Notably, the event expanded its networking opportunities through "connect sessions," which are designed to break away from traditional presentation formats. These sessions prioritize small group idea sharing and focused networking, allowing attendees to delve deeper into specific challenges and solutions. Furthermore, the clinical zone was significantly expanded, offering specialized "trail maps" tailored to attendees' specific interests. These tracks include clinical operations, data management, randomization supply, and site and patient engagement, ensuring that participants receive targeted, relevant content aligned with their functional roles. Key Takeaways: • **Strategic Importance of the Veeva Ecosystem:** The Veeva R&D and Quality Summit is identified as a premier, cross-industry event, signifying that Veeva’s platforms are central to the technological and operational strategies of pharmaceutical, biotech, and life sciences companies across R&D, Quality, Regulatory, and IT functions. • **Focus on Connected Clinical Ecosystems:** The central theme, "Better Trials for All Through a Connected Clinical Ecosystem," highlights the industry imperative to move away from siloed systems toward integrated technology solutions that link sponsors, sites, and patients for improved efficiency and data flow. • **Prioritization of In-Person Interaction:** After a period of virtual events, the emphasis on the return to in-person interaction underscores the recognized value of face-to-face networking for building robust professional relationships and accelerating collaborative innovation in technology and process development. • **Expanded Networking Formats:** The introduction of "connect sessions" moves beyond standard presentations, offering a model for structured small group idea sharing. This format is crucial for consultants and solution providers seeking deep, targeted engagement with potential clients and industry thought leaders. • **Targeted Operational Tracks:** The summit provides specialized "trail maps" catering to specific functional areas, including Clinical Operations, Data Management, Randomization Supply, and Site and Patient Engagement, indicating where the industry is focusing its immediate technological investment and process optimization efforts. • **Multifunctional Audience Engagement:** The event successfully brings together leaders and experts from diverse yet interconnected departments—Clinical, Quality, Manufacturing, Regulatory, Safety, and IT—reflecting the need for cross-functional alignment when implementing enterprise-wide technology solutions like those offered by Veeva. • **Emphasis on Patient and Site Engagement:** The specific inclusion of a track focused on "site and patient engagement" confirms that improving the user experience for clinical trial participants and investigative sites remains a high-priority area for technological innovation and process redesign. • **Technology as an Enabler for Progress:** The overarching message is that technology and process innovation are the primary drivers for bringing the life sciences industry forward, validating the need for AI and software solutions that streamline complex, regulated workflows. Tools/Resources Mentioned: * Veeva R&D and Quality Summit (Event) Key Concepts: * **Connected Clinical Ecosystem:** This concept refers to an integrated network of technology platforms (often Veeva Vault applications) that seamlessly link all stakeholders—sponsors, CROs, sites, and patients—involved in clinical trials. The goal is to improve data quality, accelerate trial timelines, and enhance the overall experience for participants and staff through unified processes and data sharing.
RIM Implementation in times of IDMP - Asphalion Webinar
Asphalion
/@Asphalion.
Jul 26, 2022
This video explores the critical intersection of Regulatory Information Management (RIM) system implementation and the ongoing transition to ISO Identification of Medicinal Products (IDMP) standards. The speaker details the current uncertainties surrounding IDMP, the phased rollout of EMA's SPOR project (including PMS and the DADI web form), and the profound impact these changes have on the pharmaceutical industry. A central theme is how RIM systems serve as essential tools to navigate IDMP compliance, emphasizing the need for digitalization, robust data governance, and strategic data migration during implementation. Key Takeaways: * **IDMP as a Digitalization Catalyst:** ISO IDMP is presented not merely as a regulatory requirement but as a significant driver for comprehensive digitalization and the establishment of strong data governance frameworks within pharmaceutical companies, necessitating standardized and interoperable data. * **RIM Systems are Core for IDMP Compliance:** Regulatory Information Management (RIM) systems are highlighted as indispensable for IDMP compliance, facilitating efficient data collection, organization, and communication. Future RIM systems are expected to directly support data submission to EMA's PMS via fire messages, evolving beyond current xEVMPD processes. * **Data Quality and Governance are Foundational:** Successful IDMP compliance and RIM implementation are contingent upon high-quality, harmonized data. Companies must prioritize data cleaning, enrichment, and mapping, integrating IDMP requirements from the initial planning stages of any RIM project. * **Navigating Phased IDMP Rollout Complexity:** The EMA's phased implementation of IDMP through the DADI web form (starting with Centrally Authorized Products (CAPs), then Nationally Authorized Products (NAPs)) introduces a complex transitional period. Organizations must plan to manage the coexistence of legacy and new systems and processes effectively. * **Strategic Implementation is Crucial:** Regardless of company size or portfolio, a well-defined strategy for IDMP compliance and RIM implementation is vital. This involves a thorough assessment of existing data structures, internal processes, technological capabilities, and future expectations to select the most compatible RIM system and implementation approach.
Kent Malmros | 2022 Veeva R&D and Quality Summit | Register Now
Veeva Systems Inc
/@VeevaSystems
Jul 26, 2022
This video serves as an invitation and strategic preview for the 2022 Veeva North America Quality and R&D Summit, hosted in Boston. Presented by Kent Malmros, Senior Director of Vault Training at Veeva, the primary goal is to encourage attendance by highlighting critical industry themes and Veeva's strategic direction. The summit is positioned as a crucial in-person event for connecting with quality and manufacturing thought leaders, offering over ten presentations from Veeva customers, live product demonstrations, and extensive networking opportunities focused on best practices for quality transformation within the life sciences sector. A central theme of the summit, and the core strategic focus articulated by Malmros, is "transforming quality management across the value chain." This theme reflects a significant shift observed in the industry, where companies—regardless of size—are adopting a broader, more holistic approach to quality initiatives. Historically, firms often focused on solving singular, isolated problems related to specific processes or system-based challenges. The new transformative approach emphasizes looking holistically at desired business impacts and designing solutions that address quality management end-to-end. This requires integrating systems and processes across R&D, manufacturing, and commercial operations to achieve comprehensive compliance and operational efficiency. Furthermore, the video highlights strategic initiatives surrounding Veeva Vault Training. Malmros promises to share how recent product announcements and developments fit into Veeva’s overarching vision to fundamentally change enterprise life sciences training. This focus on training transformation is critical for regulatory compliance, as effective, documented training is a cornerstone of GxP requirements. The integration of training strategy with the broader quality management transformation theme suggests that Veeva is positioning its solutions to support a unified, compliant, and efficient operational model, moving beyond simple document management to intelligent, integrated training delivery and tracking. The speaker emphasizes that the event is designed to provide attendees with actionable insights from both Veeva leadership and industry peers. By bringing together customers and thought leaders, the summit aims to foster guided discussions around the future of quality management and training strategy. For firms operating in the regulated life sciences space, understanding these strategic shifts—particularly the move toward holistic quality management and the evolution of Veeva’s training platform—is essential for aligning technology investments and consulting services with emerging industry best practices and compliance requirements. Key Takeaways: • **Industry Shift to Holistic Quality Management:** The life sciences sector is moving away from siloed, point-solution approaches to quality management. Companies are now seeking transformative initiatives that address quality across the entire value chain, demanding solutions that integrate R&D, manufacturing, and commercial processes. • **Focus on Business Impact:** Quality initiatives are increasingly being measured by their broader business impacts, requiring a strategic, holistic view rather than merely fixing specific system or process challenges. This necessitates technology partners who can connect quality systems (like Vault Quality) to overall operational goals. • **Veeva Vault Training Transformation:** Veeva is actively pursuing a vision to "transform enterprise life sciences training," indicating significant strategic investment and new product development in this area. Consultants should anticipate and prepare for changes in how training is managed, delivered, and integrated within the Veeva ecosystem. • **Integration of Training and Quality:** The strategic alignment of the Vault Training discussion within the R&D and Quality Summit underscores the critical link between effective, compliant training and overall quality management systems (QMS). This confirms that training solutions must be seamlessly integrated into GxP compliance frameworks. • **Strategic Opportunity in Quality Transformation:** The emphasis on "transforming quality management" signals a high-priority area for investment among pharmaceutical and biotech companies, creating demand for expert consulting services that can implement, customize, and integrate advanced quality and training platforms. • **Veeva’s Role in Compliance Evolution:** As Veeva continues to evolve its Vault platform (including Quality and Training), it is shaping the future of regulatory compliance technology. Staying current with Veeva’s strategic direction is non-negotiable for firms providing GxP and 21 CFR Part 11 compliant solutions. • **Importance of Peer Networking:** The summit structure emphasizes networking and guided discussion with Veeva customers and industry thought leaders, suggesting that practical, peer-driven best practices are driving the adoption of new quality management methodologies. • **Demand for Integrated Solutions:** The call for a broader, holistic approach to quality management validates the need for data engineering and system integration services that can connect disparate quality data sources and provide unified business intelligence dashboards. Tools/Resources Mentioned: * Veeva Vault Training * Veeva R&D and Quality Summit (Event) Key Concepts: * **Transforming Quality Management Across the Value Chain:** This concept refers to the strategic initiative of moving beyond departmental or process-specific quality fixes to implement a unified, end-to-end quality system that spans R&D, manufacturing, and commercial operations, ensuring consistent compliance and efficiency across the entire product lifecycle. * **Holistic Thinking in Quality Initiatives:** The methodology of assessing quality challenges based on their overall business impact rather than isolated system failures, leading to comprehensive, integrated solutions rather than fragmented fixes.
Introduction to the Identification of Medicinal Products (IDMP) Ontology Project
Object Management Group
/@ObjectMgmtGroup
Jul 25, 2022
This video provides an in-depth introduction to the Identification of Medicinal Products (IDMP) Ontology Project, spearheaded by the Pistoia Alliance. Presented by Heiner Oberkampf, Co-Founder & CEO of Accurids, the session outlines the critical role of ISO IDMP standards in uniquely identifying and describing medicinal products globally, driven primarily by regulatory mandates from bodies like the FDA and EMA. The core problem addressed is the current fragmentation and inconsistency in IDMP implementations across the pharmaceutical industry, largely due to the standards being published as non-machine-actionable PDF documents, leading to varied interpretations and significant data integrity risks. The project's central solution is the development of an IDMP Ontology, designed to augment existing standardization efforts by enabling deep, semantic interoperability based on the FAIR principles (Findability, Accessibility, Interoperability, Reusability). This semantic layer aims to counteract diverse implementations, facilitate automation of data processes, enhance patient safety, and foster seamless collaboration among regulators, pharma companies, suppliers, and healthcare providers. The EMA's impending enforcement of IDMP compliance from 2023 onwards underscores the urgency and importance of this initiative, which has garnered support from major pharmaceutical companies including Bayer, Novartis, Merck, Boehringer Ingelheim, Roche, GSK, J&J, Amgen, and AstraZeneca, with active collaboration with the FDA. Oberkampf details the project's modular ontology development approach, which takes the ISO standards as a starting point but restricts its scope to address specific "competency questions" derived from real-world business cases and regulatory needs. The ontology leverages semantic web standards (RDF, OWL, SKOS) and reuses foundational "common ontologies" from the EDM Council for non-pharma-specific concepts like data types, identifiers, and quantities, allowing the team to focus on complex chemical and pharmaceutical aspects. A key modeling pattern discussed is the concept of "contextualized roles," which allows for precise definitions of how a substance plays a specific role (e.g., active moiety) within another object under a given context (e.g., regulatory vs. scientific). The project uses Accurids for use case implementation and applying the ontology on actual data, and the EDM Council provides the ontology development governance and hosting environment. The presentation highlights several critical use cases, including enhancing patient safety through unambiguous product identification for pharmacovigilance, and efficiently answering complex regulatory questions such as identifying clinical trials where a specific substance was administered in a particular region. Oberkampf demonstrates how the ontology can be used to query public data (like FDA's Global Substance Registration Service and the ChEBI ontology) to identify substances with shared active moieties or specific registered identifiers. The distinction between the ontology (a few hundred conceptual definitions) and the vast data graph (millions of instances) is emphasized, with the data graph being crucial for testing the ontology's effectiveness and demonstrating its value in answering real-world problems for both public and private pharma data. Key Takeaways: * **Regulatory Imperative for IDMP:** The ISO standards for Identification of Medicinal Products (IDMP) are driven by regulatory requirements, with the EMA enforcing compliance from 2023, making robust IDMP implementation a critical industry need. * **Addressing Data Inconsistency:** The current PDF-based IDMP standards lead to varied interpretations and inconsistent implementations across the industry, posing significant risks to data integrity and hindering automation in submissions and patient safety. * **Semantic Interoperability through Ontology:** The IDMP Ontology project aims to provide deep, semantic interoperability for medicinal product data, enabling machine-actionable definitions and consistent data interpretation across diverse stakeholders. * **Leveraging FAIR Principles:** The ontology development is grounded in FAIR principles, particularly focusing on "Interoperability" to bridge disparate data systems and facilitate data exchange within and between organizations. * **Bridging Internal and External Silos:** The IDMP Ontology acts as a crucial translator, connecting simplified departmental data views within pharma companies to a common semantic definition, and enabling cross-organizational collaboration (e.g., between pharma and regulators, or between partners like Pfizer and BioNTech). * **Real-world Use Cases:** The project is driven by specific "competency questions" from pharma companies and authorities, such as identifying clinical trials for a specific substance, finding all substances with a common active moiety, or retrieving specific regulatory codes. * **Modular and Reusable Ontology Design:** The ontology is built modularly, reusing established "common ontologies" (e.g., from EDM Council) for generic concepts like identifiers, quantities, and registries, allowing the project to focus on domain-specific pharmaceutical complexities. * **Contextualized Roles for Precision:** A key modeling pattern allows for defining how a substance plays a specific role (e.g., active moiety) within another object, distinguishing between different contexts like regulatory versus scientific views. * **Importance of Persistent Identifiers:** All data objects are assigned persistent identifiers to ensure unique and unambiguous referencing, crucial for data linking and interoperability. * **Deep Chemical Linking:** Accurate matching and linking of substances rely not just on names (which can be misleading) but also on deep chemical information, specifically molecular structures, to ensure precise identification. * **Collaborative Industry Effort:** The project is a broad, open initiative involving numerous major pharmaceutical companies, regulatory bodies (FDA, EMA), and expert consultants, fostering industry-wide adoption and impact. * **Distinction Between Ontology and Data Graph:** The ontology provides the conceptual structure (hundreds of concepts), while the data graph represents the actual data instances (millions of objects), which is used to test the ontology's effectiveness in answering competency questions. * **Demonstrated Value and Future Expansion:** The project has successfully demonstrated the ontology's value on both public (FDA GSGRS) and private pharma data, with plans for parallel implementations across more companies and future phases to expand coverage beyond small molecules to biological products. **Tools/Resources Mentioned:** * **Accurids:** A tool used for implementing use cases, applying the IDMP ontology on actual data, and exploring data. * **EDM Council (Enterprise Data Management Council):** Provides the ontology development governance and hosting environment, including common ontologies (e.g., FIBO for financial business ontology, which shares governance principles). * **Pistoia Alliance:** The framing organization for the IDMP Ontology project. * **FDA Global Substance Registration Service (GSGRS):** A public data source used for testing the ontology. * **Chemical Entities of Biological Interest (ChEBI) Ontology:** A reference ontology for chemical entities, used for alignment and deeper chemical classification. * **ISO Standards (IDMP):** The foundational Identification of Medicinal Products standards (e.g., ISO 11238 on substance, 11240 on units, 11615 on medicinal products). **Key Concepts:** * **IDMP (Identification of Medicinal Products):** A set of five ISO standards providing an international framework to uniquely identify and describe medicinal products, driven by regulatory requirements. * **Ontology:** A formal, explicit specification of a shared conceptualization, used here to provide a machine-actionable, semantically rich representation of IDMP standards. * **FAIR Principles:** A set of guiding principles to make data Findable, Accessible, Interoperable, and Reusable. The IDMP Ontology specifically targets the "Interoperability" aspect. * **Semantic Interoperability:** The ability of computer systems to exchange data with unambiguous, shared meaning, crucial for automating processes and ensuring data consistency. * **Active Moiety:** The part of a substance that is responsible for its biological or pharmacological activity. * **Contextualized Roles:** A modeling pattern that allows for defining how a substance plays a specific role within another object, with the role being dependent on a particular context (e.g., regulatory, scientific). * **Persistent Identifiers (PIDs):** Unique, long-lasting identifiers assigned to data objects, ensuring they can be reliably referenced over time and across different systems. * **Molecular Graph:** A representation of a molecule's structure that captures atoms and their bonds, providing a highly accurate basis for chemical identification and matching, superior to string-based representations. **Examples/Case Studies:** * **Patient Safety/Pharmacovigilance:** The "blue pill" scenario, where a patient reports adverse symptoms after taking a medication, requiring unambiguous identification of the exact product, its ingredients, and related substances for safety assessment. * **Clinical Trial Query:** A health authority asking, "In which clinical trials were substance X with ingredient product Y registered in the EMA region administered to patients?" This question, which currently takes weeks and often yields incorrect results, is a primary driver for the ontology project. * **Shared Active Moiety:** Identifying all substances that share a common active moiety, which is critical for understanding drug families and potential cross-reactivity or safety signals. * **Specific Substance Codes:** Retrieving specific codes (e.g., EMA's EVMPD codes, FDA codes, WHO codes, internal codes) for a given substance, highlighting the complexity of identifier management. * **Cross-Organizational Collaboration:** The example of Pfizer and BioNTech collaborating on the COVID vaccine, where a standardized, semantically aligned representation of substance and manufactured item information would greatly facilitate data sharing and accelerate development.
Amazon Buys One Medical... It's In the News Everywhere!!
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 24, 2022
This video provides an in-depth analysis of Amazon's acquisition of One Medical, an advanced primary care company, for $3.9 billion. Dr. Eric Bricker, the speaker, dissects the financial performance and strategic implications of this deal, highlighting key observations about the evolving healthcare landscape. He begins by introducing One Medical as a digital health startup with 188 clinics across 17 major U.S. cities, detailing its IPO history and significant stock price decline prior to the Amazon acquisition. The core of his analysis revolves around One Medical's dual business model and the contrasting revenue generation from its "enterprise" clients (employer contracts and individual subscriptions, fee-for-service) versus its "Medicare Advantage risk" business (capitated payments, acquired through Iora Health). Dr. Bricker meticulously breaks down the revenue disparities, revealing that One Medical's Medicare Advantage segment, despite having significantly fewer members (39,000 vs. 728,000 enterprise members), generated almost equal revenue in Q1 2022 ($120 million vs. $130 million). This translates to a staggering 17 times more revenue per member annually for the capitated Medicare Advantage beneficiaries ($12,300) compared to enterprise members ($714). He points out One Medical's struggles with organic member growth (only 28% year-over-year) and consistent quarterly losses, suggesting that its growth rate for a "money-losing business" was not steep enough to satisfy Wall Street or its board. The analysis then shifts to Amazon Care, Amazon's own digital health and telemedicine service, which Dr. Bricker argues has also struggled due to an "undifferentiated offering" in a market already saturated with telemedicine incumbents. He emphasizes that Amazon's decision to acquire One Medical, a substantial $3.9 billion investment (seven times more than all AWS acquisitions combined), indicates a recognition that building a competitive healthcare solution internally was not proving successful. Dr. Bricker concludes by framing the acquisition as a "fantastic opportunity for a pivot" for Amazon. He suggests that Amazon should de-emphasize or sunset One Medical's less profitable enterprise business and focus heavily on the high-revenue, capitated Medicare Advantage risk model, emulating successful players like ChenMed and Oak Street Health. This strategic pivot, he argues, is where the "healthcare money is," particularly among older, sicker individuals who are high utilizers of healthcare services. Key Takeaways: * **Amazon's Strategic Healthcare Entry:** Amazon's acquisition of One Medical for $3.9 billion signifies a significant commitment to the healthcare sector, indicating a strategic shift and potentially a recognition of challenges with its internal Amazon Care initiative. This large investment suggests a long-term play in healthcare delivery. * **One Medical's Dual Business Model:** One Medical operates two distinct business lines: an "enterprise" model (employer/individual subscriptions, fee-for-service) serving a large member base, and a "Medicare Advantage risk" model (capitated payments) serving a smaller, but significantly more lucrative, member base through its Iora Health acquisition. * **Revenue Disparity in Primary Care:** The capitated Medicare Advantage business generates substantially more revenue per member (approximately $12,300 annually) than the enterprise fee-for-service model (approximately $714 annually), highlighting the financial attractiveness of value-based care for older, higher-utilizing populations. * **Challenges of Digital Health Utilization:** One Medical's enterprise business struggles with only 40% "activation/utilization" among employees, a common "achilles heel" for many digital health programs. This low engagement rate makes it difficult to impact the 5% of employees who drive 50% of healthcare costs. * **Importance of High-Utilizer Focus:** The video strongly advocates for monetizing advanced primary care through "high utilizers"—sicker, older individuals who are typically covered by Medicare Advantage plans. These individuals have significantly higher healthcare expenditures ($18,400+ per year for 65+ vs. $4,400 for 19-44). * **Amazon Care's Undifferentiated Offering:** Amazon Care faced market challenges due to an "undifferentiated offering" compared to existing telemedicine incumbents. This lack of a "10x better value proposition" made it difficult to unseat established providers. * **Acquisition as a Pivot Opportunity:** The One Medical acquisition presents an opportunity for Amazon to "pivot" its healthcare strategy. The speaker suggests de-emphasizing the struggling enterprise business and focusing on the more profitable Medicare Advantage risk model, leveraging One Medical's Iora Health experience. * **Benchmarking Against Successful Models:** Companies like ChenMed and Oak Street Health are cited as successful examples of advanced primary care providers that exclusively focus on capitated Medicare Advantage risk, demonstrating the viability and revenue potential of this model. Oak Street Health, for instance, serves 114,000 people with $1.4 billion in annual revenue. * **Healthcare as a Viable Niche:** Despite the complexities, healthcare is a massive industry (nearly 20% of the U.S. economy), offering significant opportunities for companies, including tech giants like Amazon, to carve out profitable and value-adding niches. * **Value-Based Care for Monetization:** The most effective way to monetize advanced primary care is through capitated payments for Medicare Advantage beneficiaries, as this model aligns incentives with managing the health of high-cost patients and allows providers to retain savings from improved outcomes. Key Concepts: * **Advanced Primary Care:** A model of primary care that often integrates digital health tools, focuses on comprehensive patient management, and may involve different payment structures beyond traditional fee-for-service. * **Digital Health:** The use of information and communication technologies to help improve human health and healthcare services. * **Capitated Payments:** A payment arrangement for healthcare service providers where a fixed amount is paid per patient per unit of time, regardless of the number or type of services provided. This shifts financial risk to the provider. * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. In healthcare, it gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, not the quality. * **Medicare Advantage (MA):** A type of private health insurance plan in the United States that provides Medicare benefits. These plans are offered by private companies approved by Medicare and often include additional benefits like vision, hearing, and dental. * **Utilization/Activation:** Refers to the rate at which members or patients engage with or use a healthcare service or program. Low utilization is a common challenge for many digital health solutions. * **Organic Growth:** The increase in revenue or membership that a company achieves through its own operations, without relying on acquisitions or mergers. Examples/Case Studies: * **One Medical:** An advanced primary care company with 188 clinics, acquired by Amazon. Its business model includes enterprise clients (fee-for-service) and Medicare Advantage risk (via Iora Health acquisition). * **Iora Health:** An advanced primary care company acquired by One Medical, specializing in taking Medicare Advantage risk through capitated payments. * **Amazon Care:** Amazon's internal digital health and telemedicine service, which struggled with market differentiation and adoption before the One Medical acquisition. * **ChenMed:** A private company cited as a successful example of a primary care provider focused on capitated Medicare Advantage risk. * **Oak Street Health:** An advanced primary care practice that exclusively focuses on capitated risk for Medicare Advantage beneficiaries, serving 114,000 people with $1.4 billion in annual revenue, demonstrating the financial viability of this model.
Veeva post Implementation.
Prana Life Sciences
/@pranalifesciences1
Jul 21, 2022
This video explores strategies for optimizing Veeva Vault post-implementation support within the life sciences industry. The speaker, a technical expert from Prana Life Sciences, discusses common challenges and presents practical solutions for improving efficiency, reducing costs, and ensuring compliance in regulated GxP environments. Key themes include the automation of user and access management, streamlining configuration support, and enhancing clinical operations processes within Veeva CTMS and eTMF. The presentation emphasizes a continuous improvement approach, leveraging technology to address manual bottlenecks and accelerate project delivery. Key Takeaways: * **Automated User & Access Management:** Significant efficiency gains can be achieved by automating Veeva user creation and deactivation. This can be done by integrating with identity management systems (e.g., SalePoint, Azure Active Directory) or using custom development (Python, Java SDKs), drastically reducing manual effort and ensuring timely access/deactivation. * **Streamlined Configuration Support:** Improving configuration support involves proactive categorization of incoming tickets to quickly identify potential change requests. Initiating change management and validation (CSV) processes earlier, along with engaging users through quick Proof-of-Concepts (POCs) during design, can reduce lead times and enhance SLA adherence. * **Enhanced Clinical Operations Efficiency:** Automation can substantially reduce the resource burden in clinical support. Specific examples include automating user provisioning and access changes for studies/sites within Veeva CTMS and eTMF, as well as automating the generation of reports for milestones and sites, leading to significant resource optimization (e.g., reducing support from 2 full-time resources to 0.5). * **Continuous Improvement in Regulated Environments:** Adopting a continuous improvement mindset, supported by regular reporting on support activities and Service Level Agreements (SLAs), is crucial for maintaining high efficiency and customer satisfaction in GxP-regulated settings, ensuring processes are consistently optimized. * **Addressing Deactivation Complexities:** While automating user deactivation can present challenges, particularly with active workflows, these can be managed by generating reports of users with active workflows, allowing for targeted reassignment of tasks before full deactivation, thus maintaining process integrity while still benefiting from automation.
An Industry Ontology for the Identification of Medicinal Products (IDMP)
Biomedical Ontology World
/@biomedicalontologyworld
Jul 18, 2022
This video introduces the Pistoia Alliance's IDMP Ontology project, which addresses the critical challenge of inconsistent interpretations of the ISO Identification of Medicinal Products (IDMP) standards within the pharmaceutical industry. Currently, IDMP standards are published as PDFs, leading to varied implementations across companies and regulatory agencies, hindering automated data processing, quality, and semantic interoperability. The project aims to augment these standards with a formal ontology, creating a semantically aligned and governed data model that acts as a "connecting bridge" for data interpretation across internal departments, suppliers, and regulators. The speaker emphasizes the importance of contextualizing complex concepts like "active moiety" to accommodate diverse scientific and regulatory perspectives, ensuring accurate representation while allowing for different expert views. The ontology is being developed collaboratively with major pharma companies and validated against real-world data from sources like FDA's GSRS, demonstrating its ability to answer specific competency questions and facilitate cross-organizational data integration for improved drug safety, innovation, and operational efficiency. Key Takeaways: * **Semantic Interoperability for Regulatory Compliance:** The IDMP Ontology directly tackles the lack of semantic alignment in pharmaceutical product data, a crucial step for achieving consistent regulatory compliance (FDA, EMA) and enabling automated data processing across the life sciences ecosystem. * **Ontologies as Foundational Data Bridges:** The project highlights the strategic value of ontologies in creating a unified "connecting bridge" for data interpretation, essential for harmonizing information flows within and between pharma companies, suppliers, and regulatory bodies. * **Contextualized Data Modeling for Complex Concepts:** The approach to modeling concepts like "active moiety" with contextual roles (e.g., regulatory, scientific, patent exclusivity) demonstrates a sophisticated method for managing inherent ambiguities and diverse expert perspectives in pharmaceutical data. This advanced data modeling is critical for developing robust custom software and AI solutions. * **Industry-Wide Collaborative Standard Setting:** The Pistoia Alliance's collaborative model, involving leading pharma companies (Bayer, Merck, GSK, Novartis, J&J) and regulatory agencies (FDA, EMA), underscores the industry's commitment to developing shared data standards that drive collective innovation, efficiency, and patient safety. * **Real-World Validation for Practical Application:** The project's emphasis on testing the ontology with actual data (e.g., FDA GSRS, pharma company data) and specific use cases ensures its practical applicability and demonstrates tangible value for solving real-world data integration and interpretation challenges, a key aspect of delivering effective consulting and software development.
Primary Care Innovation at Scale
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 17, 2022
This video, presented by Dr. Eric Bricker of AHealthcareZ, provides an in-depth analysis of ChenMed's highly successful "reimagined primary care at scale" strategy. Based on a presentation by ChenMed CEO Dr. Chris Chen to the Department of Health and Human Services, the video details how ChenMed has achieved the "triple, quadruple, quintuple aim" of increasing quality, decreasing costs, and improving physician satisfaction. Operating 130 primary care centers across 40 cities and 14 states with 5,000 employees, ChenMed takes on full capitated risk from Medicare Advantage plans, making them wholly responsible for all patient care costs, including specialty, hospitalizations, surgical, and medication expenses. This model primarily serves economically disadvantaged and minority elderly populations, with 40% of patients being dual-eligible for Medicare and Medicaid. A cornerstone of ChenMed's strategy is the intensive retraining of its primary care physicians. Dr. Bricker highlights ChenMed's belief that traditional medical school and residency training are inadequate for effective primary care. Consequently, new physicians undergo a 9-12 month fellowship focusing on leadership, influencing patient behavior change, customer service, the economics of healthcare, and documentation for care (rather than solely for billing). This specialized training addresses the 80% of health outcomes determined by patient behavior and social determinants, moving beyond the traditional 20% focus on pills, procedures, and referrals. ChenMed emphasizes proactive disease management for conditions like diabetes and congestive heart failure, shifting from reactive treatment to continuous health maintenance. Central to ChenMed's operational success is its robust technological and data infrastructure. The company developed its own proprietary Electronic Medical Record (EMR) system, which functions less as a record-keeping tool and more as an "ERP/CRM for patient care." This custom-built system hardwires effective clinical workflows directly into the software, ensuring consistent, outcome-driven care. Complementing this, ChenMed employs nearly 400 data scientists—almost 10% of its workforce—to rigorously analyze patient data. This significant investment underscores their philosophy that "data is the mother of medicine," driving evidence-based decisions rather than relying on opinions. The model further emphasizes building profound trust and providing comprehensive team-based support. Physicians manage small patient panels, typically one doctor for every 400 patients, enabling monthly visits and direct access via personal cell phone numbers, fostering strong patient-physician relationships. Each physician leads a comprehensive team including nurses, case managers, and care coordinators. On-site pharmacies dispense 90% of patient medications, significantly improving adherence. Additional services like door-to-door transportation via ChenMed minivans address logistical barriers to care, while on-site classes (e.g., tai chi, zumba, cooking) and monthly birthday celebrations combat loneliness and promote overall well-being. Physician compensation is aligned with outcomes, offering a market-comparable base salary plus a 20-30% bonus based on patient results, which has proven highly effective in recruiting top talent. The impressive outcomes include a 30-50% reduction in hospitalizations and ER visits, a 70% decrease in congestive heart failure admissions, and a 22% reduction in strokes, demonstrating the efficacy of this holistic, data-driven approach. Key Takeaways: * **Full-Risk Capitation Drives Accountability:** ChenMed's model of taking full capitated payments from Medicare Advantage plans for all patient care costs creates a powerful incentive for proactive, high-quality, and cost-effective care, aligning financial success with patient outcomes. * **Physician Retraining is Essential for Modern Primary Care:** Traditional medical education is deemed insufficient; ChenMed invests in a 9-12 month fellowship to train physicians in leadership, patient behavior influence, customer service, healthcare economics, and documentation for care, not just billing. * **Proprietary EMR as a Workflow Engine:** ChenMed's custom-built EMR system is more than a record keeper; it's an "ERP/CRM for patient care" that hardwires effective clinical workflows, ensuring consistent, data-driven care delivery and operational efficiency. * **Significant Investment in Data Science:** With nearly 400 data scientists (10% of its workforce), ChenMed emphasizes that "data is the mother of medicine," using rigorous analytics to translate patient data into actionable clinical insights and workflow improvements. * **Trust-Building Through Small Patient Panels and Direct Access:** Physicians manage small patient loads (1:400 ratio), conduct minimum monthly visits, and provide direct cell phone access, fostering deep trust and strong patient-physician relationships crucial for behavior modification. * **Comprehensive Team-Based Care:** The physician leads a multidisciplinary team including nurses, case managers, and care coordinators, ensuring holistic patient support that extends beyond the doctor's direct interaction. * **Outcome-Based Physician Compensation:** Physicians receive a market-comparable base salary plus a 20-30% bonus tied directly to patient outcomes, effectively aligning financial incentives with quality care and attracting high-caliber talent. * **Focus on Social Determinants of Health and Behavior Modification:** Recognizing that 80% of health is determined by behavior and social factors, ChenMed's training and care model proactively addresses these areas, moving beyond traditional clinical interventions. * **Proactive Disease Management:** The strategy shifts from reactive treatment to proactive management of chronic conditions like diabetes and congestive heart failure, aiming to prevent exacerbations and hospitalizations through continuous engagement. * **High Medication Adherence via On-Site Pharmacies:** Dispensing 90% of patient medications directly at the clinic significantly improves compliance, addressing a major barrier to effective treatment and reducing hospitalizations. * **Addressing Non-Clinical Barriers to Care:** Services like door-to-door transportation and on-site social activities (e.g., tai chi, birthday celebrations) tackle practical and social barriers like mobility issues and loneliness, which significantly impact patient health. * **Quantifiable Positive Outcomes:** The model consistently delivers impressive results, including 30-50% reductions in hospitalizations and ER visits, a 70% decrease in CHF admissions, and a 22% reduction in strokes, validating its effectiveness. * **Scalable and Replicable Methodology:** Dr. Chen's generous sharing of the ChenMed methodology suggests that these principles and systems can be adapted and scaled to improve primary care outcomes more broadly. **Tools/Resources Mentioned:** * **ChenMed's Proprietary Electronic Medical Record (EMR) System:** Described as an "ERP/CRM for patient care" that hardwires clinical workflows. **Key Concepts:** * **Full Capitation:** A payment model where a healthcare provider receives a fixed amount per patient per period, regardless of the services provided, making them financially responsible for all care. * **Patient-Centered Medical Home:** A model of care where a patient's primary care physician leads a team that coordinates all aspects of the patient's care. * **Triple/Quadruple/Quintuple Aim:** Frameworks for optimizing health system performance, typically focusing on improving patient experience, improving population health, reducing per capita cost of healthcare, and improving the work life of healthcare providers. * **Social Determinants of Health:** Non-medical factors that influence health outcomes, such as socioeconomic status, education, neighborhood, and access to transportation. * **Proactive Care:** An approach to healthcare that focuses on anticipating and preventing health issues before they become severe, rather than reacting to acute problems. * **Data Science as the Mother of Medicine:** The philosophy that rigorous data analysis and evidence-based insights should drive medical practice and decision-making, rather than opinions or traditional practices.
Delivery with Excellence
Veeva Systems Inc
/@VeevaSystems
Jul 14, 2022
This video, produced by Veeva Systems, provides an internal perspective on the core tenets of its global Business Consulting team, defining the standards and philosophy encapsulated by the phrase "Delivery with Excellence." The consensus among the consultants interviewed is that true excellence extends far beyond merely guaranteeing quantifiable results, such as good reports or specific numbers. Instead, it centers on a deep, empathetic understanding of the client's underlying objectives and operational challenges, requiring consultants to "put ourselves in the customer's shoes" to devise creative and effective solutions. The philosophy emphasizes rigorous focus and execution, demanding that the consulting team sets a consistently high internal bar for performance. This commitment ensures they can meet the complex and evolving needs of their life sciences clientele. A critical component of this delivery standard is the design of solutions that are not only insightful—providing novel understanding of the client’s data or market position—but also highly actionable. The goal is to move beyond theoretical recommendations to create practical, implementable strategies. Furthermore, the concept of excellence incorporates the qualitative experience of the client relationship. Consultants stress the importance of ensuring customers feel understood, taking the necessary time to fully grasp the root question being asked, and bringing the precise information needed to the discussion. This process requires securing customer buy-in and trust. The ultimate aim is to translate complex challenges into "dramatic simple solutions" that customers can easily execute. This adaptability and flexibility are crucial, as the team recognizes that circumstances can change rapidly, necessitating a responsive approach that always prioritizes the client's needs above internal convenience or rigid processes. The entire methodology is sustained by a culture of passion, open discussion, and continuous attention to customer feedback, which Veeva views as essential for maintaining its differentiated reputation. Key Takeaways: * **Excellence Beyond Metrics:** Consulting success is defined qualitatively, going beyond guaranteeing good numbers or quantifiable reports to focus on solving the client's fundamental business objectives and operational challenges. * **Empathy-Driven Solutioning:** Consultants must adopt a deep, empathetic approach, requiring them to "put ourselves in the customer's shoes" to accurately diagnose problems and develop solutions tailored to their specific environment. * **High Internal Performance Bar:** Achieving excellence necessitates setting and maintaining a rigorous internal standard for performance and execution, ensuring the consulting team is prepared to meet the sophisticated demands of pharmaceutical and life sciences clients. * **Insightful and Actionable Design:** Solutions must serve a dual purpose: they must provide novel, data-driven insights while simultaneously being highly actionable, offering clear, practical steps for the client to implement. * **Focus on Simplicity and Execution:** The objective is to develop "dramatic simple solutions" that clients can easily execute, prioritizing clarity and ease of adoption over overly complex or theoretical frameworks. * **Client Buy-In and Trust:** Effective delivery requires bringing the right information to the client and ensuring they "buy into the process," making co-creation and alignment on the solution path a mandatory step. * **Flexibility and Adaptability:** Consultants must maintain flexibility to adapt quickly to changing client needs and market dynamics, understanding that circumstances can shift and requiring a responsive strategy adjustment. * **Prioritizing Client Needs:** The core principle of excellence is consistently putting the client's needs first, even when it conflicts with internal firm priorities or established procedures. * **Understanding the Root Question:** Consultants must dedicate time to fully understand the core question the customer is asking, ensuring that the proposed solution addresses the underlying problem rather than just treating a superficial symptom. * **Relationship Management:** A significant component of excellence is ensuring the customer feels positive about the working relationship, emphasizing clear communication, transparency, and a passionate approach to the job. * **Continuous Differentiation:** Maintaining a reputation for excellence is an ongoing process, requiring an "open discussion" culture and continuous attention to customer feedback to ensure the consulting approach remains differentiated and relevant in the market. Tools/Resources Mentioned: * Veeva Systems (Implied context, as the consulting team operates within this ecosystem) Key Concepts: * **Delivery with Excellence:** A consulting philosophy that prioritizes deep client understanding, actionable solution design, high execution standards, and relationship management over mere quantifiable results. * **Insightful and Actionable Solutions:** A methodology requiring that consulting deliverables not only provide new knowledge or understanding (insightful) but also include clear, executable steps for implementation (actionable). * **High Bar:** The internal standard of performance and quality set by the consulting team to ensure they meet the rigorous demands of the pharmaceutical and life sciences sector.
Life Sciences in Europe Breaking Down the Barriers
Veeva Systems Inc
/@VeevaSystems
Jul 13, 2022
This video provides an in-depth exploration of the current state and future direction of the European life sciences industry, particularly in the post-pandemic era. Featuring an interview with Chris Moore, President of Veeva Europe, the discussion centers on the critical need to break down long-standing barriers and embrace new ways of working to accelerate clinical research and enhance patient outcomes. The conversation highlights the palpable energy and optimism within the industry to institutionalize the rapid advancements made during the pandemic, moving beyond siloed approaches towards a more connected, efficient, and patient-centric ecosystem. The core theme revolves around the tension between the industry's historical "muscle mass" – a century of ingrained, silo-driven processes – and the transformative potential of modern technology, especially in the wake of the COVID-19 pandemic. The speakers emphasize that while the pandemic forced unprecedented innovation and demonstrated what was truly possible under pressure, there's a risk of reverting to "business as usual." Veeva's role is positioned as a key enabler, providing foundational technology to connect internal operations and, increasingly, to integrate the broader life sciences ecosystem. This involves removing "worthless administrative tasks" that hinder productivity and focusing on a holistic, connected approach to clinical trials. The discussion progresses to the critical importance of patient-centricity and site-centricity, asserting that these concepts must move beyond buzzwords to become fundamental drivers of change. The vision for "digital trials" (preferred over "decentralized clinical trials") is framed as a patient-driven problem, aiming to get the right patients into the right trials efficiently, accelerate the process, and ensure a less intrusive experience. The ultimate goal is to connect the dots between sponsors, sites, and patients to fundamentally change the economics of the industry for the better and bring medicines to the broader population faster. The interview concludes with a "magic wand" thought experiment, revealing a strong desire for immediate, seamless integration of patient enrollment, data capture, and sharing across all stakeholders, coupled with a collective amnesia for the "we must do things this way" mentality. Key Takeaways: * **Post-Pandemic Momentum for Change:** The life sciences industry is experiencing a renewed eagerness to "do things differently and better" following the pandemic, which served as a turning point by removing excuses for traditional, slow processes. There's a strong desire to institutionalize the rapid innovations seen during COVID-19. * **Breaking Down Silos is Paramount:** A major frustration across the industry is the "silo-driven approach" to R&D. While comfortable due to a century of established practices, these silos are now seen as significant barriers to efficiency and effectiveness, requiring a concerted effort to dismantle them. * **Optimism Meets Pragmatism for Enduring Change:** Great things happen when optimism about new possibilities is balanced with a pragmatic approach to implementation. The industry is currently in a phase where it believes in new ways of working but is also focused on the practical steps required to make these changes happen. * **Technology as an Enabler of Connectivity:** The advent of technology that genuinely connects and joins things up is crucial for overcoming inertia. Platforms like Veeva are seen as vital for providing "ground-up technology" that enables internal integration and helps the industry connect into the broader ecosystem. * **Veeva's Evolving Role:** Initially focused on providing capabilities to join up internal operations, Veeva's next wave of responsibility is to help the industry connect into the wider ecosystem. This includes removing administrative burdens and raising overall productivity. * **Patient and Site Centricity are Non-Negotiable:** Patient-centricity and site-centricity must become more than just buzzwords; they need to be genuinely embedded in how clinical trials are designed and executed. The "magic happens" when these elements are connected rather than dealt with in separation. * **Focus on "Digital Trials" for Better Outcomes:** The concept of "digital trials" (preferred over "decentralized clinical trials") is about leveraging technology to achieve patient-driven goals: getting the right patients into the right trials efficiently, accelerating the process, and ensuring a painless and unobtrusive experience for participants. * **Urgency for Integrated Clinical Development:** There is an "impatience" to achieve a state where patient enrollment, data capture, and sharing with investigators, sites, sponsors, and CROs are seamlessly integrated. This integration is seen as critical to increasing access to studies, accelerating timelines, and improving the patient experience. * **Overcoming "Muscle Mass" and Inertia:** The industry must actively combat the "100 years of muscle mass" or "muscle memory" that perpetuates old ways of doing business. Maintaining optimism and a "can-do" attitude is vital to break through these ingrained barriers. * **Risk of Squandering Post-COVID Learnings:** A significant risk is that the industry might "squander" the lessons and capabilities demonstrated during the pandemic by reverting to "business as usual," allowing old excuses for difficulty to resurface. * **Radical Reassessment of the Rule Book:** The industry has an opportunity to "revisit the rule book in a really radical and fundamental way," moving beyond the mentality of "we must do things this way" to truly innovate and improve study design and execution. Key Concepts: * **Silo-Driven Approach:** The traditional, fragmented method of working in the life sciences industry, particularly in R&D, where different departments or functions operate in isolation, hindering collaboration and efficiency. * **Optimism Meets Pragmatism:** A framework for achieving lasting change, where forward-thinking ideas and belief in new possibilities are grounded in practical planning and execution. * **Patient-Centricity:** Designing and conducting clinical trials with the patient's needs, preferences, and experiences at the forefront, aiming for greater comfort, convenience, and engagement. * **Site-Centricity:** Focusing on the needs and experiences of clinical trial sites, aiming to streamline processes, reduce administrative burden, and improve their ability to conduct trials effectively. * **Digital Trials:** A comprehensive approach to clinical trials that leverages technology to connect various aspects of the trial process, from patient recruitment and data capture to site management, to enhance efficiency, patient experience, and data quality. This term is preferred over "decentralized clinical trials" to emphasize the holistic digital transformation rather than just the location of activities. * **Muscle Mass/Memory:** A metaphor used to describe the deeply ingrained habits, processes, and resistance to change that have accumulated over decades within the industry. Examples/Case Studies: * **Roche's Medical Testing Device:** The video highlights Roche's ability to introduce a whole new medical testing device in a matter of months during the lockdown. This example serves as a powerful demonstration of the industry's capacity for rapid innovation and thinking/acting differently when faced with urgent needs.
Why your business needs a cloud-based quality management system
Qualio
/@QualioHQ
Jul 11, 2022
This video provides an in-depth exploration of the critical shift from paper-based to cloud-based quality management systems (QMS) within the life sciences industry. Presented by Kelly Stanton, Director of Quality at Qualio, at the American Biomanufacturing Summit 2022, the session highlights why digital, cloud-powered QMS solutions are no longer just an option but an indispensable necessity for quality-conscious businesses aiming to bring life-saving products to market faster. Stanton, drawing from her two decades of experience in pharmaceutical and medical device sectors, underscores the inefficiencies of traditional paper systems and champions a lean, efficient, and compliant approach to quality management that prioritizes actual regulatory requirements over excessive, often unnecessary, documentation. The presentation systematically breaks down the challenges posed by paper-based quality systems, such as the creation of organizational silos, the inordinate amount of time spent on administrative tasks like manual data entry into spreadsheets, and the inability to effectively analyze and leverage critical data for improvement. Stanton reveals compelling statistics, noting that 38% of companies still rely solely on paper and spreadsheets for quality work, with 25-50% of a working day spent on administrative tasks and 50-53% on gathering and tracking information for QA, auditing, and training. She argues that this focus on manual control prevents organizations from dedicating resources to quality improvement, hindering their journey towards a "world-class" quality posture where processes actively support activities and patient safety. Transitioning to the benefits, the speaker elaborates on how cloud-based eQMS solutions address these pain points by uniting teams, processes, and data. Key advantages include enhanced data availability, reduced manual data entry, and the power of API integrations to consolidate information from disparate tools like learning management systems, ERPs, Jira, Asana, and Git repositories into a central source of truth. This flexibility, configurability, and remote accessibility are crucial in today's globalized and often remote work environments. Stanton also provides practical migration tips, emphasizing the importance of asking the right questions, electing a change champion, and avoiding the "paving the cow path" pitfall—where existing, inefficient paper processes are merely digitized without being optimized for the new electronic environment. She illustrates these concepts with case studies of pharmaceutical manufacturers, Irresist and Expression Therapeutics, demonstrating successful transitions and the resulting efficiencies and audit readiness. The discussion culminates with a focus on audit best practices and regulatory acceptance. Stanton asserts that an electronic QMS ensures perpetual audit readiness, eliminating the weeks of preparation typically associated with gathering physical documents. It facilitates easier information flow, controlled access via permissioning, and real-time tracking of audit findings and corrective actions (CAPAs), significantly reducing administrative overhead and meeting times. In the Q&A segment, she addresses the critical issue of regulatory acceptance, confirming that agencies globally, including those outside the U.S. and under PICS, generally accept electronic systems, provided the control of data, information, and configuration can be clearly demonstrated. She also offers valuable advice on managing quality touchpoints with a heterogeneous network of partners (CROs, suppliers), advocating for a risk-based approach in procedures rather than overly prescriptive requirements for specific e-signature tools, thereby promoting flexibility and trust in vendor qualification. Key Takeaways: * **Imperative for Digital Transformation:** A significant portion of life science companies (38%) still rely on paper and spreadsheets for quality management, leading to substantial inefficiencies and hindering progress towards quality improvement. * **Inefficiencies of Paper Systems:** Paper-based systems create organizational silos, demand excessive administrative time (25-50% of a workday on data entry/reporting), and prevent effective data analysis, diverting resources from critical quality improvement initiatives. * **Cloud-Based eQMS Benefits:** Electronic Quality Management Systems (eQMS) facilitate faster operations, unite teams and processes, make data readily available for analysis, and eliminate the need for manual data transcription, thereby enhancing overall efficiency. * **Strategic API Integrations:** A robust eQMS acts as a central source of truth, leveraging API integrations to pull data from other essential tools (e.g., LMS, ERP, Jira, Asana, Git), allowing different teams to work in their preferred systems while maintaining quality oversight. * **Flexibility and Accessibility:** Cloud-based eQMS offers flexibility, configurability, and remote access, which are crucial for distributed teams, outsourced operations, and adapting to evolving business structures, especially in a post-pandemic world. * **Audit Readiness and Efficiency:** An eQMS ensures constant audit readiness by centralizing documentation, providing controlled access, and streamlining the tracking and resolution of audit findings and CAPAs, significantly reducing preparation time and administrative burden. * **Avoiding "Paving the Cow Path":** When migrating to an eQMS, organizations should seize the opportunity to re-evaluate and optimize existing processes rather than simply digitizing inefficient paper-based workflows, which can lead to long-term pain and customization issues. * **Importance of a Champion:** Electing a respected internal champion is vital for managing the cultural change associated with adopting a digital quality system, fostering buy-in, spreading awareness, and securing senior management support. * **Regulatory Acceptance:** Regulatory agencies worldwide are increasingly accepting of electronic quality systems, provided companies can demonstrate robust control over data, information, and system configuration, focusing on the intent of regulations rather than specific methodologies. * **Managing Heterogeneous Partner Systems:** When dealing with multiple partners using different quality or e-signature systems, procedures should be written to accept compliant electronic signatures generated in a compliant manner, rather than restricting to specific tools, leveraging vendor qualification and risk assessment to ensure data integrity. * **Risk-Based Approach to Procedures:** Procedures should focus on areas of true risk where patient safety or product quality could be compromised, avoiding overly prescriptive details that can stifle efficiency and collaboration without adding significant value. * **Qualio's Lean Philosophy:** Qualio advocates for a "lean" quality system that focuses on what is actually required by regulations, aiming for efficiency, simplicity, and ease of use to make quality management more effective and even "fun." **Tools/Resources Mentioned:** * **Qualio:** A cloud-based quality management software. * **Jira, Asana, Git:** Examples of tools that can be integrated with an eQMS via APIs, particularly for software development and project management. * **Adobe Sign, Docusign:** Examples of electronic signature methodologies discussed in the context of partner integrations. * **G2 Reviews:** A platform where customers can review software, mentioned as a source of customer feedback for Qualio. **Key Concepts:** * **Cloud-based Quality Management System (QMS):** A system for managing quality processes and documentation hosted on cloud infrastructure, offering remote access, scalability, and integration capabilities. * **Electronic Quality Management System (eQMS):** A digital system that automates and manages quality processes, documentation, and records, replacing traditional paper-based methods. * **"Paving the Cow Path":** A term describing the mistake of digitizing existing, often inefficient, manual processes directly into a new system without first optimizing or redesigning them. * **Lean Quality System:** An approach to quality management that focuses on efficiency, eliminating waste, and adhering strictly to essential regulatory requirements rather than excessive or redundant documentation and processes. * **API Integrations:** The ability of software systems to communicate and exchange data with each other, allowing for a unified view of information across different platforms. * **Regulatory Compliance (FDA, EMA, PICS):** Adherence to standards and regulations set by bodies like the U.S. Food and Drug Administration, European Medicines Agency, and Pharmaceutical Inspection Co-operation Scheme, which are critical in the life sciences. **Examples/Case Studies:** * **Irresist:** A pharmaceutical manufacturing company with 75 users, producing OTC products. They transitioned from a paper-based system to Qualio's eQMS, expanding quality participation from 6 core QA staff to 60 people across the organization. This shift enabled them to efficiently maintain documentation for hundreds of specialty therapeutics and become continuously ready for FDA audits. * **Expression Therapeutics:** A company that built a new 43,000 square foot manufacturing facility and proactively adopted an eQMS from day one, going paper-free from the start. This allowed them to focus their time and resources on developing their manufacturing processes, as their quality system processes (like document control and training) were already efficiently managed electronically.
Employer Healthcare Priorities: 1) Lower Deductible, 2) Behavioral Health, 3) Expand Virtual Care
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Jul 10, 2022
This video provides an in-depth exploration of employer healthcare priorities for the 2023 plan year, drawing insights from the Mercer Employer Survey. Dr. Eric Bricker, the speaker, begins by establishing the context: despite widespread public and media focus on high healthcare costs, the vast majority of employers are strategically prioritizing benefit enhancements over cost reduction. This counter-intuitive finding is attributed to the current low unemployment rate (3.6% as of June 2022), which makes employee attraction and retention (A&R) a paramount business challenge for organizations across all sizes. The presentation then delves into the top three ways employers plan to enhance their healthcare benefits. The primary enhancement is making healthcare more affordable for employees, often by offering lower deductible plans or even copay-only options, signaling a potential shift away from the consumer-directed high-deductible health plans that gained prominence post-2007 financial crisis. Secondly, employers are focusing on behavioral health, predominantly through "enhanced" Employee Assistance Programs (EAPs) and the introduction of self-service technology resources like websites and apps. Lastly, virtual care is being expanded beyond traditional telemedicine to include virtual behavioral health visits and virtual primary care, viewed as a benefit enhancement rather than a cost-cutting measure. Dr. Bricker emphasizes that these employer priorities stand in stark contrast to popular healthcare finance discussions, which often center on price transparency and Pharmacy Benefit Manager (PBM) controversies. He argues that employers, who collectively pay more for healthcare than any other entity in the U.S., are not strategically prioritizing these cost-containment efforts. This observation leads to a crucial piece of advice for digital health companies, brokers, and consultants: to succeed in the employer-sponsored benefits market, it is essential to "bend with the trend" and align offerings with the current employer focus on affordability, behavioral health, and virtual care enhancements, rather than solely pushing cost-reduction narratives. The video concludes by highlighting the inconsistent nature of employers as a force for change in healthcare, noting that their priorities tend to shift towards cost containment only during economic downturns and high unemployment, making them an unreliable long-term driver of systemic change. Key Takeaways: * **Employer Priority Shift:** For the 2023 plan year, 70% of employers are prioritizing benefit enhancements over lowering healthcare costs, a significant departure from common public discourse on healthcare finance. * **Attraction & Retention (A&R) as a Driver:** The primary reason for this strategic shift is the acute need for employee attraction and retention, fueled by a historically low unemployment rate (3.6% as of June 2022). * **Focus on Affordability:** The number one way employers are enhancing benefits is by making healthcare more affordable for employees, with 41% offering lower deductible plans or even copay-only options, moving away from the high-deductible health plan trend. * **Enhanced Behavioral Health Access:** Employers are addressing behavioral health needs through enhanced Employee Assistance Programs (EAPs) and by adding self-service technology resources (e.g., websites, apps), often as a low-marginal-cost approach to expanding access. * **Expansion of Virtual Care:** Virtual care is being expanded beyond traditional urgent-care-focused telemedicine to include virtual behavioral health and virtual primary care, positioned as a benefit enhancement rather than a cost-saving strategy. * **Disregard for Cost-Containment Buzzwords:** Despite widespread media attention, employers are not prioritizing price transparency initiatives or addressing PBM controversies as strategic priorities for their 2023 health plans. * **Market Alignment for Digital Health Companies:** Digital health companies, brokers, and consultants are advised to align their offerings with current employer priorities (affordability, behavioral health, virtual care enhancements) to gain market traction, rather than solely focusing on healthcare cost reduction. * **Inconsistent Force for Change:** Employers are not a consistent force for change in the healthcare system; their priorities fluctuate with economic cycles, shifting to cost containment primarily during recessions when unemployment is high. * **Opportunity for AI/Software Solutions:** The emphasis on "self-service technology resources" for behavioral health and the expansion of "virtual care" presents an opportunity for AI and software development firms to create innovative solutions that align with these employer priorities. * **Understanding Client Context:** For firms serving the pharmaceutical and life sciences industries, understanding that their client companies (as employers) are focused on employee benefits and retention is crucial, as this impacts overall operational strategy and investment capacity. Tools/Resources Mentioned: * Mercer Employer Healthcare Survey (2023 Plan Year) * Bureau of Labor Statistics (BLS) unemployment data * KFF (Kaiser Family Foundation) health benefits survey Key Concepts: * **A&R (Attraction & Retention):** The strategic business imperative for employers to attract and keep skilled employees, heavily influencing benefit design. * **Enhanced EAP (Employee Assistance Program):** Expanded or improved versions of traditional EAPs, often incorporating new technologies or broader service offerings for mental health and well-being. * **Virtual Care vs. Telemedicine:** Virtual care is presented as a broader concept encompassing ongoing virtual relationships (e.g., virtual primary care, virtual behavioral health), distinct from traditional telemedicine which often refers to episodic, urgent virtual visits with no continuity. * **Consumer-Directed Health Plans (CDHPs) / High Deductible Health Plans (HDHPs):** Health plans with higher deductibles, often paired with Health Savings Accounts (HSAs), which gained popularity as a cost-containment measure but are now being re-evaluated by employers. * **PBM (Pharmacy Benefit Manager):** Companies that manage prescription drug benefits for health plans, often criticized for practices like spread pricing and rebate structures. Examples/Case Studies: * **Shift from HDHPs:** The video notes a historical shift where CDHPs/HDHPs grew from 2% to 33-35% of employee plans since 2007, but employers are now "dialing it back" by offering lower deductible options. * **Recessionary Shifts:** Historical examples include the pivot to HDHPs during the Great Financial Crisis (2007-2009) and the rise of Health Maintenance Organizations (HMOs) in the early 1990s, both driven by recessions and a focus on cost containment.
Flex Databases eTMF – electronic Trial Master File
Flex Databases
/@Flexdatabases
Jul 8, 2022
This video provides an in-depth demonstration of Flex Databases' electronic Trial Master File (eTMF) system, designed to offer comprehensive 24/7 visibility and management of all trial documentation within clinical research. The presentation walks through the system's user interface and core functionalities, emphasizing its role in streamlining clinical operations, ensuring data integrity, and maintaining regulatory compliance. The speaker's approach is a feature-by-feature walkthrough, showcasing how users can navigate, manage, and report on trial documents from a high-level dashboard down to individual file details, all while highlighting the system's configurability and user-centric design. The demonstration begins with an overview of the cross-project dashboard, which presents customizable widgets and reports, along with a centralized area for eTMF messages and personal activities. This initial view allows users to quickly grasp their tasks and project statuses across all allocated projects. The system then transitions to a deeper dive into individual project work, illustrating how an eTMF provides an instant understanding of project progress through a structured view of document completion percentages and statuses. Key functionalities for document interaction are highlighted, including quick search filters, detailed document information (size, author, last updated), options for review, metadata management, and in-system editing and version control. A significant portion of the demonstration focuses on the system's robust document handling and compliance features. This includes the ability to send documents directly from the system with an audit trail, OCR recognition for text search within scanned documents, and a secure recycle bin for deleted files. The video also details various upload methods, including drag-and-drop and email integration, and showcases the system's electronic signature capabilities, which add a compliant extra page with date, time, signatory, and reason. The presentation concludes with an exploration of reporting tools, including master reports and TMF fulfillment reports, and the administrative area for managing user permissions, configurable metadata sets, and document templates, such as those recommended by the DIA (Drug Information Association). The emphasis on comprehensive logging for archiving, emails, and electronic signatures underscores the system's readiness for audits and inspections. Key Takeaways: * **Centralized Trial Documentation Management:** The Flex Databases eTMF system offers a unified platform for managing all clinical trial documentation, providing 24/7 visibility and a "helicopter view" of eTMF processes, which is crucial for large-scale clinical operations. * **Customizable Dashboards and Reporting:** Users are greeted with a personalized dashboard featuring configurable widgets and reports, allowing for immediate insights into cross-project activities, messages, and individual task lists, enhancing daily workflow efficiency. * **Granular Project Overview:** Within individual projects, the system provides an instant understanding of progress through a structured view that displays document completion percentages and statuses, enabling proactive management and identification of bottlenecks. * **Advanced Document Interaction and Metadata Management:** The eTMF supports comprehensive document lifecycle management, including quick search by various criteria (name, country, site, completeness, type), detailed document information, in-system editing, version control, and configurable metadata fields, some of which are auto-sourced. * **Integrated Communication and Collaboration:** The system facilitates collaboration by allowing users to start chats or leave comments directly on documents, streamlining communication among team members and stakeholders. * **Robust Compliance and Audit Readiness:** Critical compliance features include audit trails for sent documents, a secure recycle bin for deleted files (ensuring nothing is permanently lost), and comprehensive logs for archiving, emails, and electronic signatures, preparing organizations for audits and inspections. * **Compliant Electronic Signatures:** The system generates electronic signatures that are compliant with regulatory requirements, adding an extra page to signed documents detailing the date, time (UTC), signatory name, and reason for signature (e.g., reviewed, approved). * **Efficient Document Upload and OCR:** Multiple convenient methods for document upload are available, including drag-and-drop and emailing documents directly into the system, with automatic allocation based on email subject. OCR recognition enables full-text search within scanned documents, improving discoverability. * **Configurable Permissions and Access Control:** The administrative area allows for detailed management of user permissions, enabling access rights to be set per user and per folder, ensuring data security and adherence to roles-based access control. * **Templates and Placeholders for Standardization:** The system supports the use of templates, including those recommended by organizations like the DIA, and placeholders, which guide users on expected document types and naming conventions, promoting standardization and consistency across trials. * **Export and Archiving Capabilities:** Users can export all documents from a project for offline work or download the entire TMF as a ZIP file with its original structure, providing flexibility for external review or long-term archiving. * **Dedicated Auditor/Inspection Access:** A "TMF Master copies" section can be configured to provide auditors or inspectors with access only to final, approved documents, preventing them from seeing drafts or internal communications, thus streamlining the inspection process. **Tools/Resources Mentioned:** * **Flex Databases eTMF:** The primary electronic Trial Master File system demonstrated. * **Flex Databases CTMS, LMS, PM& Budgeting, EDC, Pharmacovigilance automation systems:** Other products offered by Flex Databases, indicating a broader suite of clinical trial management solutions. * **HR database:** A supportive module mentioned for sourcing email addresses when sending documents. * **DIA (Drug Information Association) templates:** Referenced as a source for recommended document templates within the system. **Key Concepts:** * **eTMF (electronic Trial Master File):** A digital system for managing all essential documents of a clinical trial, ensuring they are complete, accurate, and readily available for regulatory inspection. * **Cross-project area:** A centralized dashboard view that aggregates information and activities across all clinical projects a user has access to. * **Metadata:** Data that provides information about other data. In an eTMF, this includes details like document author, date uploaded, version, and specific trial-related attributes, all of which are configurable. * **OCR (Optical Character Recognition):** Technology that enables the system to recognize text within images or scanned documents, making the content searchable. * **Audit Trail:** A chronological record of system activities, including document uploads, edits, deletions, and electronic signatures, essential for regulatory compliance and accountability. * **Electronic Signatures:** Digital signatures that are legally binding and comply with regulatory requirements (e.g., 21 CFR Part 11), providing proof of review or approval with specific details like date, time, and reason. * **Placeholders:** Predefined slots or markers within the eTMF structure that indicate where specific documents are expected, helping to track completeness and guide document submission. * **TMF Master Copies:** A designated section within the eTMF, typically for final, approved documents, which can be selectively shared with external parties like auditors or regulatory inspectors.
Degas Wright's top stock picks: Veeva Systems, IBM, and Dow
CNBC Television
/@CNBCtelevision
Jul 7, 2022
This video features Degas Wright, Founder, CEO, and CIO of Decatur Capital, presenting his top stock picks, focusing on Veeva Systems, IBM, and Dow. The primary purpose of the segment is to provide investment recommendations and the rationale behind them, offering insights into the financial health and strategic directions of these companies. The discussion begins with a specific focus on Veeva Systems, highlighting its strong performance and strategic positioning within the medical services and life sciences sectors. Wright elaborates on Veeva Systems, emphasizing the leadership of its CEO and founder, Peter, and the company's dedicated focus on research within medical services and life sciences. He points out that nine out of ten elements of Veeva's business have shown increased earnings, projecting a healthy profit margin of 20%. A key aspect highlighted is Veeva's commitment to innovation, demonstrated by its reinvestment of 20% of its revenues back into research and development to foster continuous innovative solutions. This commitment to R&D is presented as a significant differentiator and a driver of future growth, especially in an environment where raising earnings estimates is considered rare. Following the discussion on Veeva, the segment transitions to IBM, which Wright describes as a transformed entity, distinct from its historical "Big Blue" image. He notes IBM's strategic shift towards cloud computing, artificial intelligence (AI), and computer consulting. The financial attractiveness of IBM is underscored by its 5% dividend yield, a 15% return on invested capital, and a 27 times multiple, suggesting the company is effectively navigating new technological landscapes. The final stock pick is Dow Chemical, where Wright praises the CEO's leadership in cost reduction and debt restructuring, which has led to higher earnings and increased investment in new projects, including artificial turf. The segment concludes with a brief macroeconomic outlook, with Wright expressing concerns about a potential recession, citing the Atlanta Fed's negative GDP forecast, despite a strong labor market. Key Takeaways: * **Veeva Systems' Strategic Focus:** Veeva Systems is highlighted for its dedicated focus on research in medical services and life sciences, aligning perfectly with IntuitionLabs.ai's target industry and specialized services. This indicates a strong, growing market for industry-specific solutions. * **Commitment to Innovation:** A significant insight is Veeva's reinvestment of 20% of its revenues into Research and Development. This strategy ensures the continuous development of innovative solutions, suggesting a dynamic and evolving platform ecosystem that IntuitionLabs.ai can leverage and contribute to. * **Strong Financial Performance:** Veeva's projected 20% profit margin and increased earnings across nine out of ten business elements underscore its robust financial health, providing confidence in the stability and growth potential of a key platform partner for IntuitionLabs.ai. * **Leadership and Vision:** The speaker specifically commends Peter, Veeva's CEO and founder, for his leadership, implying that strong, visionary leadership is a critical factor in the success and strategic direction of companies in the life sciences technology space. * **Market Opportunity in Life Sciences Tech:** The positive outlook on Veeva reinforces the significant market opportunity within the life sciences technology sector, where specialized solutions and continuous innovation are highly valued. * **IBM's AI and Cloud Transformation:** IBM's strategic pivot towards cloud and AI, alongside computer consulting, signals the broader industry trend towards these technologies. While not directly pharma-specific, it highlights the increasing importance of AI and cloud infrastructure, which are core to IntuitionLabs.ai's offerings. * **Value of R&D Investment:** The emphasis on Veeva's R&D investment serves as a best practice, demonstrating that allocating significant resources to innovation is crucial for sustained growth and market leadership in specialized technology sectors. * **Economic Headwinds vs. Industry Specific Growth:** The video briefly touches on broader economic concerns (potential recession) but contrasts this with specific company strengths like Veeva's, suggesting that well-positioned companies in critical sectors can still thrive even during economic downturns. Tools/Resources Mentioned: * **Veeva Systems:** A cloud-based software company focused on the global life sciences industry, offering solutions for CRM, content management, and data. * **IBM:** A multinational technology and consulting company, noted for its focus on cloud, AI, and computer consulting. * **Dow Chemical:** A global materials science company. * **Atlanta Fed:** The Federal Reserve Bank of Atlanta, mentioned for its GDP forecast. * **National Bureau of Economic Research (NBER):** An American private nonprofit research organization, referenced for its role in announcing recessions. Key Concepts: * **Return on Invested Capital (ROIC):** A profitability ratio that indicates the percentage return that a company makes from capital previously invested. * **Dividend Yield:** The financial ratio that shows how much a company pays out in dividends each year relative to its stock price. * **Multiple (P/E Ratio):** The price-to-earnings ratio, a valuation multiple used to compare a company's current share price relative to its per-share earnings. * **GDP (Gross Domestic Product):** The total monetary or market value of all the finished goods and services produced within a country's borders in a specific time period. * **Recession:** A significant decline in economic activity spread across the economy, lasting more than a few months, normally visible in real GDP, real income, employment, industrial production, and wholesale-retail sales.
What is Veeva Vault RIM? | Implementation of Veeva Vault RIM into a Life Science Company
kyyah abdul
/@kyyahabdul
Jul 5, 2022
This video provides an in-depth exploration of Veeva Vault RIM, a critical cloud-based platform designed to streamline global regulatory processes within life science companies. The speaker, a regulatory professional, offers a user-centric perspective, demystifying the platform's functionalities and highlighting its transformative impact on document management and regulatory compliance. She emphasizes that while Veeva's official definition might seem convoluted, Vault RIM essentially functions as a comprehensive, centralized document management system for all regulatory-related documents within an organization. The presentation delves into the core components of the Veeva Vault RIM suite, which includes the Vault Platform, Vault Quality Docs, Vault Regulations, and Vault Submissions. The speaker contrasts this integrated solution with the fragmented and often inefficient systems previously used in the industry, such as Liquid Insight, Rosetta Phoenix, GDMRS, and even basic tools like Google Docs. She recounts personal experiences where smaller companies struggled with quality control and version management due to disparate applications and manual processes, particularly for large regulatory documents like protocols or briefing books. Veeva Vault RIM addresses these challenges by consolidating various tools—from housing documents and SOPs to building the eCTD backbone—into a single, unified application. A significant portion of the video is dedicated to explaining the practical application and workflow benefits of Veeva Vault RIM. The speaker details how the platform facilitates critical regulatory processes, such as authoring, pre-publishing, and final approval of documents. She illustrates an "authoring workflow" where medical writing initiates a document for review, allowing multiple stakeholders to collaborate simultaneously within the document while maintaining stringent version control. The system ensures that only changes made directly within the Vault are reflected, preventing issues arising from downloaded or externally modified files. Once a document is approved, it becomes locked, and any subsequent changes trigger an "up-versioning" process (e.g., from version 1.0 to 1.1 or 2.0), creating a clear audit trail. The platform also allows for flexible categorization of documents, typically by product, ensuring all related submissions and materials are easily accessible. The speaker also notes its capability to manage quality documents and SOPs for training, similar to specialized systems like MasterControl, but within a broader, integrated framework. Key Takeaways: * **Veeva Vault RIM's Core Purpose:** Veeva Vault RIM is a cloud-based platform that centralizes and streamlines global regulatory processes for pharmaceutical and life science companies, enhancing visibility, data quality, and agility in document management. * **Consolidated Document Management:** The platform serves as a comprehensive document management system, housing all regulatory documents, SOPs, and related materials in one unified application, eliminating the need for multiple disparate tools. * **Addressing Legacy System Challenges:** It solves common problems faced with older systems like Liquid Insight, Rosetta Phoenix, GDMRS, or even Google Docs, which often led to poor version control, quality inconsistencies, and workflow inefficiencies, especially for large regulatory documents. * **Integrated Suite Components:** The Veeva Vault RIM suite comprises several key tools, including the Vault Platform, Vault Quality Docs, Vault Regulations, and Vault Submissions, offering a holistic solution for various regulatory needs. * **Streamlined Regulatory Workflows:** The platform supports end-to-end regulatory workflows, from initial document authoring and collaborative review to pre-publishing formatting and final approval processes, ensuring a structured and controlled progression. * **Robust Version Control:** A standout feature is its advanced version control system, which allows multiple users to edit documents simultaneously while ensuring all changes are tracked and saved within the system, preventing external modifications from disrupting the official record. * **"Up-Versioning" for Audit Trails:** Once a document is approved, it becomes locked. Any subsequent changes automatically trigger an "up-versioning" (e.g., from 1.0 to 1.1 or 2.0), providing a clear, auditable history of all modifications and approvals. * **Broad User Adoption:** Veeva Vault RIM is widely used by regulatory professionals across all levels, from entry-level associates to senior managers, underscoring its essential role in daily operations within life science companies. * **Flexible Document Categorization:** The platform allows companies to categorize documents effectively, typically by product, making it easy to locate all submissions and materials related to a specific therapeutic area or product line. * **Quality Document Management:** Beyond regulatory submissions, Vault RIM also functions as a quality document management tool, capable of housing SOPs and supporting training processes, similar to specialized systems like MasterControl. * **Organizational Adoption Considerations:** While highly beneficial, smaller companies (5-15 people) might find the initial expense of a Veeva system prohibitive. Organizations are advised to inquire about informational sessions as they grow to determine if it's a suitable investment. * **Career Pathway for Individuals:** For individuals interested in careers in submissions management or regulatory operations, understanding and gaining proficiency in Veeva Vault RIM is invaluable, as it is a prevalent tool in the industry. **Tools/Resources Mentioned:** * Veeva Vault RIM * Veeva Vault Platform * Veeva Vault Quality Docs * Veeva Vault Regulations * Veeva Vault Submissions * Liquid Insight (legacy tool) * Rosetta Phoenix (legacy tool) * GDMRS (Global Document Regulatory System - legacy tool) * Google Docs (legacy tool for small companies) * MasterControl (quality document management system, compared to Vault Quality Docs) **Key Concepts:** * **Regulatory Information Management (RIM):** The systematic process of managing and tracking all information and documents related to regulatory submissions, approvals, and compliance throughout the product lifecycle in the life sciences. * **Cloud-based Platform:** A software system hosted on the internet, accessible from anywhere, offering scalability and centralized data management. * **Version Control:** A system that manages changes to documents over time, allowing users to track revisions, revert to previous versions, and ensure document integrity. * **eCTD Backbone:** The electronic Common Technical Document structure, a standardized format for submitting regulatory information to health authorities, which Veeva Vault RIM helps build and manage. * **Authoring Workflow:** A structured process for creating and reviewing documents, involving multiple contributors and reviewers, with defined roles and deadlines. * **Pre-publishing Workflow:** The stage where documents are formatted, checked for compliance with submission standards, and prepared for final submission. * **Approval Process:** The final stage in document management where designated authorities review and formally approve a document, often locking it from further changes without a new version. * **Quality Documents (QDocs):** Documents related to a company's quality management system, such as Standard Operating Procedures (SOPs), quality manuals, and training records.