Aware of Pharma Lifecycle and how Veeva Vault linked to it? Here it is #veeva #veevavault #pharma

This video provides an in-depth exploration of the pharmaceutical industry's lifecycle and demonstrates how Veeva Vault applications are strategically implemented to support each stage. The speaker emphasizes that a strong understanding of the pharma domain is crucial for anyone working with Veeva Vault, as the platform is specifically designed for the unique needs of pharmaceutical clients. The presentation systematically breaks down the entire drug development and commercialization process, highlighting the critical activities undertaken by pharma companies globally and how documentation and management are handled.

The discussion begins by segmenting the pharma lifecycle into two primary areas: Research & Development (R&D) and Commercial. Within R&D, the process starts with scientists investigating diseases and developing potential formulas. Once a formula shows promise, it undergoes rigorous clinical trial operations, initially tested on animals, with all findings meticulously documented. These trials span significant periods, often over a year, with continuous monitoring and verification of test cases. A successful outcome, typically exceeding 90% efficacy, leads to the crucial step of seeking regulatory approval from authorities in various countries, such as the FDA in the US. This approval process involves thorough verification of documentation and clinical trial adherence to established models and standards, marking the completion of the R&D phase.

Transitioning to the Commercial section, the video explains how approved medicines reach patients. This involves medical representatives (medical reps) from pharmaceutical companies engaging with doctors, who then prescribe the medicines. The video clarifies that commercial applications are essential for facilitating this interaction. Throughout both the R&D and Commercial phases, Veeva Vault emerges as a central, integrated platform. For R&D, particularly clinical trial operations and documentation, Veeva offers 10-12 specialized clinical applications, including Vault EDC, RTSM, eTMF, CTMS, and Site Connect. These applications serve as an Enterprise Content Management (ECM) tool, enabling scientists and medical personnel to upload, route, and approve documents through integrated workflows.

Following clinical completion, the focus shifts to regulatory activities, supported by Veeva's Regulatory Vault applications such as Registrations, Submissions, Publishing, and Submission Archive. These tools facilitate electronic document approval and signing by regulatory authorities, streamlining the approval process for new medicines. In the commercial realm, Veeva provides PromoMats for promotional materials, MedComms for medical communication documents, and MedInquiries. These commercial applications are seamlessly linked to Veeva CRM, which is built on Salesforce, allowing medical reps to use platforms like iPads to present information to doctors, ultimately leading to prescriptions. Crucially, a dedicated Quality Vault, encompassing applications like QMS, Quality Docs, Validation Management, Product Surveillance, LIMS, and Training, oversees all quality-related documents, standard operating procedures (SOPs), and training materials across the entire lifecycle, ensuring compliance and operational excellence.

Key Takeaways:

• Pharma Lifecycle Segmentation: The pharmaceutical industry operates through a distinct two-phase lifecycle: Research & Development (R&D) and Commercial. Understanding this fundamental structure is essential for navigating the industry.
• R&D Process Overview: The R&D phase involves disease investigation, formula development, extensive pre-clinical (animal) and clinical trials, meticulous documentation, and rigorous verification of test outcomes before seeking regulatory approval.
• Regulatory Approval is Paramount: Obtaining approval from country-specific regulatory authorities (e.g., FDA) is a critical gateway for any medicine to enter the market, requiring comprehensive documentation and adherence to established models.
• Commercialization Strategy: The commercial phase focuses on bringing medicines to patients, primarily through medical representatives engaging with doctors who then prescribe the products, supported by specialized commercial applications.
• Veeva Vault as an Enterprise Content Management (ECM) Solution: Veeva Vault serves as a comprehensive ECM platform designed specifically for the pharmaceutical industry, managing all documentation, workflows, and approval processes from R&D through commercialization.
• Veeva Clinical Vault for R&D: A suite of 10-12 Veeva Clinical Vault applications (e.g., EDC, RTSM, eTMF, CTMS, Site Connect) supports every aspect of clinical trial operations, documentation, and data management.
• Veeva Regulatory Vault for Compliance: Regulatory activities are streamlined by Veeva Regulatory Vault applications (e.g., Registrations, Submissions, Publishing, Submission Archive), enabling electronic approvals and managing submissions to health authorities.
• Veeva Commercial Vault for Marketing & Communications: Commercial operations leverage applications like PromoMats for promotional materials, MedComms for medical communications, and MedInquiries for managing inquiries, all crucial for doctor engagement.
• Veeva CRM Integration: Veeva CRM, built on the Salesforce platform, is tightly integrated with commercial Vault applications, facilitating sales and marketing efforts, including approved emails and CLM (Closed Loop Marketing) presentations to healthcare professionals.
• Veeva Quality Vault for GxP Adherence: A dedicated Quality Vault manages all quality-related documents, Standard Operating Procedures (SOPs), training records, and validation management (e.g., QMS, Quality Docs, LIMS), ensuring compliance with GxP and other regulatory standards across the entire product lifecycle.
• End-to-End Support: Veeva offers a comprehensive ecosystem of 20-30 applications that collectively provide end-to-end support for the entire pharmaceutical lifecycle, from initial research to post-market surveillance.
• Importance of Domain Knowledge: A deep understanding of the pharmaceutical domain and its regulatory landscape is indispensable for effectively implementing and utilizing Veeva Vault solutions.
• Workflow Automation and Electronic Approvals: Veeva Vault significantly enhances operational efficiency and compliance by providing robust workflow automation and electronic approval processes for critical documents and activities.

Tools/Resources Mentioned:

• Veeva Vault (general platform)
• Veeva CRM (tied to Salesforce)
• Veeva Clinical Vault applications: Vault EDC, Vault RTSM, Vault eTMF, Vault CTMS, Vault Site Connect
• Veeva Regulatory Vault applications: Registrations, Submissions, Publishing, Submission Archive
• Veeva Commercial Vault applications: PromoMats, MedComms, MedInquiries
• Veeva Quality Vault applications: QMS, Quality Docs, Validation Management, Product Surveillance, LIMS, Training
• Salesforce (underlying platform for Veeva CRM)
• iPads (used by medical reps for presentations)

Key Concepts:

• Pharma Life Cycle: The complete journey of a pharmaceutical product from initial research and development to market commercialization and post-market activities.
• R&D (Research & Development): The phase involving scientific investigation, formula creation, pre-clinical testing, and human clinical trials to develop new medicines.
• Clinical Trials: Systematic investigations in humans or animals to evaluate the safety and efficacy of a new drug or treatment.
• Regulatory Approval: The process by which governmental health authorities (e.g., FDA, EMA) review and approve new drugs for market entry based on scientific evidence of safety and efficacy.
• Commercial Operations: Activities related to marketing, sales, and distribution of approved pharmaceutical products.
• Medical Representatives (Medical Reps): Pharmaceutical sales professionals who engage with healthcare providers to promote and educate about their company's products.
• Enterprise Content Management (ECM): A system used to manage and store organizational documents and other content related to organizational processes. Veeva Vault functions as a specialized ECM for the life sciences.
• GxP (Good Practice): A collection of quality guidelines and regulations that ensure products are consistently produced and controlled according to quality standards appropriate for their intended use. Implied by the focus on quality and regulatory compliance.
• 21 CFR Part 11: (Implied by electronic signatures and regulatory compliance) A regulation by the FDA that sets requirements for electronic records and electronic signatures.