Archives: Agenda

• Overview of outsourcing models: Full-Service Outsourcing (FSO), Functional Service Provider (FSP), and in-house
• Pros and cons of each model and how to select the best fit for your trial
• When hybrid approaches (mixing outsourcing and in-house) are more effective than fully outsourcing or keeping trials fully internal
• Understanding why FSP is gaining popularity among sponsors and how it can help meet trial timelines

• Empirical Data quantifying the magnitude of the problem
• Identification of Opportunities to optimise protocol design and improve clinical trial performance
• Case examples of strategies and their impact

• Opportunities most resonating within panel member companies
• Strategies and tactics to address these opportunities
• Implementation challenges and how to overcome them
• Areas of future focus and opportunity

Moderator: Ken Getz, Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development

Harnessing the convergence of high-fidelity data with advanced AI is now essential for de-risking clinical trials and accelerating therapies to patients. What if the distance between a draft protocol and a validated study execution plan was reduced to a single, unified simulation?

Join Medidata’s Rob Buka for a deep dive into the future of holistic trial design and planning. Learn how advanced modeling and simulation capabilities within a central workspace can revolutionize trial operations. This session will illustrate Medidata’s strategy for optimizing protocol design, predicting trial outcomes, and achieving greater clinical and operational success in the next generation of drug development.