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

• What are the biggest barriers preventing patients from enrolling in clinical trials today?
• How can sites and sponsors improve recruitment strategies to reach the right patients faster?
• What role can digital tools, data, and patient engagement play in accelerating enrollment?
• How can collaboration between sponsors, CROs, sites, and patient communities transform recruitment outcomes?

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.

• Full regulatory compliance supported by robust documentation and end‑to‑end traceability
• Complete transparency with no hidden or unexpected costs or fees
• Streamlined management designed to avoid any additional workload for study teams

For emerging biotechs and biopharmas, the path from early-phase trials to global development is filled with operational and strategic risk. Increasing protocol complexity, fragmented vendor landscapes, and varying regulatory expectations add layers of uncertainty. In this talk, Adam Marsh will outline key inflection points where risk can be proactively mitigated, from study design through execution and scale-up. Attendees will leave with a clearer framework for reducing execution risk while enabling faster, more confident decision-making.