Season 1, Episode 3: Strengthening Safety Oversight for CRO-Sponsor Partnerships

This video provides an in-depth exploration of strengthening safety oversight in CRO-Sponsor partnerships within pharmacovigilance (PV), hosted by David Kološić of Veeva Systems Inc. The discussion features Martijn van de Leur (Chief Commercial Officer) and Olga Asimaki (Head of International QPPV Office and Global Medical Information) from Biomapas, a Contract Research Organization (CRO). The conversation delves into the evolving landscape of PV outsourcing, the critical role of technology like Veeva Volt Safety, the challenges and opportunities presented by automation and Artificial Intelligence (AI), and how Qualified Persons for Pharmacovigilance (QPPVs) are adapting to these shifts while maintaining regulatory compliance.

The discussion begins by establishing the importance of CROs in the pharmaceutical industry, particularly in PV, regulatory affairs, medical information, and clinical research. Martijn and Olga share their extensive backgrounds in PV, highlighting the historical context of outsourcing, from early "massive outsourcing projects" with control challenges to the current trend of increased trust and integrated partnerships. They identify key drivers for outsourcing, including cost efficiency, access to specialized expertise, talent attraction and retention, and the need for scalability to adapt to fluctuating resource demands. A significant shift is noted from purely transactional relationships to strategic partnerships where CROs act as an extension of the sponsor's team, offering advisory roles and sharing best practices gleaned from working with diverse clients.

A central theme is the adoption of advanced technology to facilitate these partnerships and enhance PV operations. Biomapas's early adoption of Veeva Volt Safety is presented as a case study, driven by the need to replace outdated systems and provide greater transparency and control to sponsors. The speakers emphasize how cloud-based systems like Volt Safety enable real-time visibility, collaborative workflows (e.g., medical review, unblinding in clinical trials), and standardized processes, which are crucial for building trust and ensuring inspection readiness. The conversation then transitions to the QPPV perspective on technology, with Olga stressing that patient safety and regulatory compliance are paramount. She distinguishes between basic automation (like RPAs) and true AI, advocating for a strong foundation of trusted processes and clear oversight before embracing advanced digital transformation, ensuring compliance is not compromised.

The latter part of the podcast critically examines the hype surrounding AI in PV. Martijn, with 20 years in the industry, reflects on the slow but significant evolution from paper-based systems to paperless, then to cloud technology, and now to automation. While automation is seen as a tangible "next stage of the revolution," he expresses skepticism about the current state of AI for end-to-end PV automation, citing challenges like data privacy (not being able to mix customer data for training) and the limited data available for smaller clients to train robust AI systems. Olga suggests that current practical AI applications are more likely to be supportive tools, such as in document authoring, content summarization, and generating text based on references, rather than fully autonomous decision-making. Both speakers envision a future (by 2030) where AI-driven signal detection and case processing are seamlessly integrated with real-time data sources, leading to predictive analytics, proactive compliance, and a sustainable, scalable PV system that can manage exponentially growing data volumes.

Key Takeaways:

• Evolution of PV Outsourcing: Outsourcing in pharmacovigilance has evolved from cost-driven, often challenging, large-scale projects to more integrated, trust-based partnerships. This shift is driven by the need for specialized expertise, talent management, and scalable solutions that CROs can provide.
• Strategic CRO-Sponsor Partnerships: The relationship between CROs and sponsors is moving beyond transactional service provision to a collaborative partnership model. CROs are increasingly seen as an extension of the sponsor's team, offering advisory insights and implementing best practices across multiple clients.
• Transparency and Oversight through Technology: Modern cloud-based PV systems, such as Veeva Volt Safety, are crucial for fostering trust and transparency in outsourced operations. They provide sponsors with real-time visibility into cases, data, and workflows, allowing for direct involvement in critical steps like medical review and unblinding.
• Standardization as a Key Driver: The industry is increasingly moving towards standardization in PV processes and system configurations. Utilizing default configurations of validated systems like Veeva Volt Safety simplifies operations, reduces customization costs, and enhances inspection readiness by aligning with health authority expectations.
• QPPV Perspective on Technology Adoption: For QPPVs, patient safety and regulatory compliance remain the highest priorities. Digital transformation, including automation and AI, must be built upon a strong foundation of trusted processes, data visibility, and clear oversight to ensure compliance is never compromised.
• Distinguishing Automation from AI: It's important to differentiate between basic automation (e.g., RPAs) and advanced AI in PV. While automation is already delivering practical benefits, true AI for end-to-end PV processes is still in its early stages and requires careful validation and quality control.
• AI's Current Practical Applications: Currently, AI is more realistically implemented as a supportive tool in PV, particularly for tasks like document authoring, generating content summaries from references, and assisting with text creation, rather than fully replacing human decision-making. Human review and approval remain essential.
• Challenges for AI in PV: Significant hurdles for widespread AI adoption include data privacy concerns (inability to pool data from multiple clients for training) and the lack of sufficient, diverse data from individual small clients to effectively train robust AI models.
• Regulatory Lag and Uncertainty: The pace of technological advancement often outstrips regulatory evolution, creating uncertainty for QPPVs. Clear, concrete guidance from regulatory authorities is needed to enable the industry to confidently lean into innovation without compromising compliance.
• Continuous Validation and Proactive Change Management: Validation of PV systems and tools should not be a one-time event but a continuous process, adapting to evolving needs and configurations. Proactive change management is vital to ensure successful implementation and adoption of new technologies.
• Future Vision for PV (2030): The future of PV is envisioned as a seamless integration of AI-driven signal detection and case processing with trusted, real-time data sources. This will lead to connected, intelligent safety systems capable of predictive analytics, anticipating compliance needs, and supporting data-driven decisions.
• Technology as a Necessity for Scalability: With increasing case volumes and pressure to control costs, technology is no longer a "nice-to-have" but a "must" for PV departments. It is essential for achieving scalability, sustainability, and operational efficiency without exponential cost increases.

Tools/Resources Mentioned:

• Veeva Volt Safety: A cloud-based safety database system used by CROs and pharmaceutical companies for pharmacovigilance operations.

Key Concepts:

• Pharmacovigilance (PV): The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
• CRO-Sponsor Partnerships: Collaborative relationships between Contract Research Organizations (CROs) and pharmaceutical/biotech sponsors, particularly in outsourcing specialized services like pharmacovigilance.
• QPPV (Qualified Person for Pharmacovigilance): A designated individual within a marketing authorization holder (or CRO acting on their behalf) responsible for the establishment and maintenance of the pharmacovigilance system.
• Automation (RPA): The use of technology to perform tasks with minimal human intervention, often referring to Robotic Process Automation (RPA) for repetitive, rule-based tasks.
• Artificial Intelligence (AI) / Large Language Models (LLMs): Advanced computational systems designed to simulate human intelligence, including learning, reasoning, and problem-solving. In PV, this includes potential applications for data analysis, signal detection, and document generation.