Veeva Systems - DIA 2012 Editor's Take Video

This video, filmed at the 2012 DIA annual meeting, features an interview with Jennifer Goldsmith, then Vice President of Veeva Vault, discussing how cloud technology and Software as a Service (SaaS) were transforming the life sciences industry. The conversation, hosted by Taran Gro of PharmaVOICE, provides a foundational understanding of the shifts occurring in the pharmaceutical and biotech sectors and how cloud solutions were emerging as critical enablers for agility, efficiency, and compliance. Goldsmith highlights the significant challenges faced by the industry due to globalization, evolving regulatory landscapes, and the increasing complexity of collaboration ecosystems, positioning cloud as the technological answer to these demands.

Goldsmith elaborates on the fundamental shifts observed in the 15 years leading up to 2012, including the globalization of processes, the rapid expansion of regulatory and business requirements, and the transformation of collaboration from simple in-office interactions to vast networks involving partners, co-marketing entities, co-development partners, and trusted vendors like Clinical Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). She emphasizes that these changes placed immense pressure on life sciences companies to be agile and flexible. Cloud and SaaS, in particular, were presented as key technology enablers for rapid change, offering solutions to overcome the traditional hurdles of on-premise systems.

Two primary examples illustrate the power of cloud technology. First, in enabling external partner collaboration, SaaS dramatically reduced the time required to bring partners like CROs into a system, transforming a process that once took weeks or months to get behind a firewall and learn a system into a matter of minutes. Second, for managing rapid changes in R&D regulatory requirements and documentation, SaaS applications, with their frequent release cycles (typically 3-4 times a year), allowed for much quicker implementation of changes (3-9 months) compared to the lengthy 18-36 month cycles of traditional on-premise systems. This accelerated response time allows organizations to remain compliant and focus more on innovation rather than being bogged down by outdated technology.

The discussion further delves into the efficiencies, cost savings, and process improvements brought by cloud-based products. A significant transition highlighted is the move away from extensive customization, prevalent in traditional systems, towards configuration using best practices embedded within SaaS applications. This approach not only reduces deployment time and costs associated with maintaining customizations but also allows companies to leverage industry-standard workflows. Furthermore, SaaS implementations foster greater end-user fidelity, as users are involved from day one, leading to smoother User Acceptance Testing (UAT) processes (days instead of weeks or months) and higher overall satisfaction. Goldsmith concludes by describing SaaS as an "appreciating asset" that continuously consumes enhanced capabilities, contrasting it with traditional on-premise systems that become "depreciating assets" the moment they go live, requiring costly and time-consuming upgrades every few years. This continuous currency allows life sciences companies to stay current with evolving business and regulatory requirements, exemplified by end-to-end promotional materials management processes that incorporate medical, legal, and regulatory review, with vendors handling updates for specific regulatory changes like the UK self-certification process.

Key Takeaways:

• Cloud as an Agility Enabler: Cloud and Software as a Service (SaaS) are crucial technologies for enabling agility and flexibility within the life sciences industry, addressing the demands of globalization, rapid regulatory changes, and complex collaboration ecosystems.
• Accelerated External Collaboration: SaaS significantly reduces the time required to onboard and enable external partners, such as CROs, in R&D submission systems, transforming a process that traditionally took weeks or months into a matter of minutes.
• Rapid Regulatory Response: Unlike on-premise systems with lengthy 18-36 month update cycles, SaaS applications typically release new features and regulatory updates 3-4 times a year, allowing life sciences organizations to respond to changing requirements within 3-9 months.
• Shift from Customization to Configuration: Cloud-based solutions promote a move from extensive, costly customization to leveraging best practices through configuration, which accelerates deployment, reduces maintenance costs, and ensures adherence to industry standards.
• Enhanced End-User Engagement and Satisfaction: SaaS implementation methodologies encourage end-user participation from day one, leading to smoother User Acceptance Testing (UAT) processes (reduced from weeks/months to days) and higher overall user satisfaction.
• Software as an Appreciating Asset: SaaS platforms are described as "appreciating assets" because they continuously provide enhanced capabilities through regular updates, ensuring users always have access to current features and regulatory compliance.
• On-Premise Systems as Depreciating Assets: In contrast, traditional on-premise systems are considered "depreciating assets" as they begin losing currency to business requirements the day they go live, requiring significant time and money for major upgrades every 18-48 months.
• Focus on Core Innovation: By offloading the burden of infrastructure maintenance and software updates to SaaS vendors, life sciences companies can redirect their focus and resources towards their core business of innovation and product development.
• End-to-End Process Management: SaaS applications offer comprehensive, out-of-the-box solutions for complex processes like promotional materials management, covering everything from concept and strategy to medical, legal, and regulatory review, distribution, and withdrawal.
• Automated Compliance Updates: SaaS vendors proactively incorporate regulatory changes (e.g., UK self-certification processes) into their platforms, ensuring all users automatically gain access to updated capabilities without individual effort.
• Veeva's Pioneering Role: Veeva Systems, particularly with its Veeva Vault product, is highlighted as a pioneer in providing SaaS and cloud-based solutions tailored for the regulated content management needs of the life sciences industry.

Tools/Resources Mentioned:

• Veeva Vault
• Veeva Systems
• Software as a Service (SaaS)
• Cloud technology

Key Concepts:

• Globalization of Processing: The shift from local to global operations within the life sciences industry.
• Collaboration Ecosystems: The vast network of partners, co-marketing entities, co-development partners, and trusted vendors (e.g., CROs, CMOs, sales organizations) that life sciences companies engage with.
• Agility and Flexibility: The ability of an organization to rapidly respond to changing business and regulatory requirements.
• Customization vs. Configuration: Customization involves altering source code to meet specific needs, while configuration involves setting up existing features to meet requirements without changing the core code, often leveraging best practices.
• Appreciating vs. Depreciating Assets: SaaS is an appreciating asset due to continuous updates, while on-premise software is a depreciating asset due to its static nature post-deployment.
• User Acceptance Testing (UAT): The final phase of software testing where end-users verify that the system meets their requirements.
• Promotional Materials Management: The end-to-end process of creating, reviewing (Medical, Legal, Regulatory - MLR), distributing, monitoring, and withdrawing promotional content in a compliant manner.

Examples/Case Studies:

• External Partner Collaboration: Bringing Clinical Research Organizations (CROs) behind a firewall for R&D submission systems, reduced from weeks/months to minutes with cloud.
• Regulatory Change Implementation: The contrast between 18-36 month cycles for on-premise systems to implement regulatory changes versus 3-9 months for SaaS applications with 3-4 annual releases.
• Promotional Materials Management Process: An end-to-end process from concept to distribution and withdrawal, including Medical, Legal, and Regulatory (MLR) review, with examples like changes to the UK self-certification process being handled by the SaaS vendor.