How can trial partners interact and collaborate?

This video, presented during a Veeva Systems event and featuring perspectives from major industry players like Janssen, Syneos Health, and IACT Health, addresses the critical and unsustainable operational crisis facing the clinical trial ecosystem. The core message is that the methodologies and processes that have governed clinical research for the last two decades are fundamentally obsolete and incapable of handling the current demands of pharmaceutical development. The speaker highlights a severe and growing disparity: the massive, increasing volume of new clinical studies that need to be conducted globally is colliding head-on with a "diminishing number of quality clinical research sites."

This collision point—where the volume of studies fails to "gel" with the limited capacity of the research infrastructure—creates a systemic bottleneck that threatens the speed and efficiency of bringing new therapies to market. The current model relies heavily on a small, globally constrained network of sites, which are often overburdened and operate using outdated, manual, or fragmented systems. The implication is clear: the industry must abandon its reliance on legacy processes and embrace comprehensive digital transformation to optimize collaboration and resource utilization among trial partners.

The necessity for improved interaction and collaboration among sponsors, CROs, and research sites is presented as the only viable path forward to maximize the efficiency of the scarce, high-quality site resources. This operational challenge directly points to the need for advanced technology solutions, including robust data engineering to integrate disparate systems, and AI/LLM tools capable of automating complex tasks like site feasibility assessment, patient enrollment forecasting, and regulatory documentation. By leveraging innovative technology, the life sciences sector can move toward a more scalable, resilient, and compliant clinical operations model that can effectively manage the current study volume without compromising research quality.

Key Takeaways:

• Methodological Obsolescence: The clinical trial industry is operating with methodologies that are 20 years old, rendering them incapable of efficiently managing the current high volume of global studies and leading to operational failure points.
• Critical Site Capacity Constraint: There is a recognized and severe shortage of high-quality clinical research sites globally, creating an unsustainable bottleneck that limits the industry's ability to execute necessary trials quickly and effectively.
• Collaboration as a Necessity: Enhanced interaction and collaboration among all trial partners (sponsors, CROs, and sites) are not optional but essential for maximizing the utilization and performance of the limited high-quality research sites available.
• Need for Operational Paradigm Shift: The industry must move away from simply trying to force studies through the existing, small network of sites and instead adopt new operational models, such as decentralized trials (DCTs) and AI-driven site selection, to distribute the burden.
• Data Integration Imperative: To address the site capacity crisis, sponsors and CROs require sophisticated data engineering services to integrate real-time performance data from sites, enabling proactive management and resource allocation.
• AI for Site Optimization: The challenge of finding and maintaining "quality" sites necessitates the use of AI and predictive analytics to better assess site feasibility, forecast enrollment, and standardize operational workflows across the network.
• Focus on Quality over Volume: The emphasis on the "diminishing number of quality clinical research sites" suggests that the industry needs solutions that enhance the operational quality and compliance of existing sites, rather than just seeking out new, potentially inexperienced centers.
• Regulatory Compliance in Modernization: Any shift toward new methodologies and digital tools must maintain rigorous adherence to regulatory standards (e.g., FDA, GxP, 21 CFR Part 11), ensuring that efficiency gains do not compromise data integrity or patient safety.
• Veeva Ecosystem Optimization: Given the context of the Veeva event, the solution involves maximizing the investment in regulated enterprise platforms like Veeva CRM and Clinical Operations suites, integrating them with custom AI agents for intelligent automation.

Tools/Resources Mentioned:

• Veeva Systems (Contextual platform for clinical and commercial operations)
• Janssen (Pharmaceutical Sponsor)
• Syneos Health (Contract Research Organization - CRO)
• IACT Health (Clinical Research Site Network)

Key Concepts:

• Clinical Site Constraint: The systemic limitation imposed by the small, globally distributed number of high-quality research sites, which cannot keep pace with the increasing volume of clinical studies.
• Methodological Obsolescence: The recognition that traditional, manual, and siloed approaches to trial execution are no longer viable in the modern, high-volume pharmaceutical R&D environment.