- Reimagining responsibilities across clinical trial functions in an AI- and automation-driven environment
- Evolving from task-based roles to strategic, insight-driven contributors across operations and data functions
- Redefining entry-level roles as technology reshapes foundational skills, expectations, and career pathways
- Identifying the new capabilities required to ensure technology enhances, not replaces the expertise of clinical trial professionals
Archives: Agenda
How Real-World Data Drives Enrollment of Undiagnosed Patient Populations
Leveraging peer-reviewed science to bridge the gaps in diagnoses to connect more patients with clinical trials
- We show how Patient and Site Burden Indexing helps quantify barriers to clinical trial participation, setting the foundation for smarter recruitment strategies
- How to go beyond the traditional site feasibility by combining real-world data from patient feasibility studies and patient population insights to identify and reach more patients
- Real-life case studies from our peer-reviewed papers demonstrating how data-driven, tailored campaigns highlight diagnosis gaps, improve patient reach, and de-risk enrollment outcomes
AI Patient Crew – A Patient-led project for Involvement in AI Tool Design
- The challenge
- The proposed solution
- What worked well
- Even better if…
Chairs closing remarks and Drinks Reception
Implementing FDA’s Project Optimus in an ongoing trial – a case study
Navigating the Evolving Biosimilars Landscape: Application of new FDA and EMA Guidance as illustrated with a biosimilar case study and implications for CROs
- Learning from real-world case studies to accelerate biosimilar development and approval.
- Understanding the EMA’s reflection paper and its role in shaping regulatory expectations.
- Examining how a rapidly changing regulatory environment impacts development strategies.
- Assessing the implications for CROs in supporting sponsors through this transition.
Reserved for Event Sponsor
Built for Biotech: A Fit for Purpose FSP Model That Scales with Innovation
- Designed for biotech: A Fit‑for‑Purpose FSP model, built with agility, to tailor to unique biotech needs
- Scales with innovation: Flexible resourcing that grows with evolving pipelines, addressing clinical trial complexities in an ever-changing clinical trial and geopolitical landscape
- Integrated expertise: Dedicated teams embedded as an extension of the sponsor with laser-focus on developing assets to time and quality
- Enabling progress: Supporting development from early stages through commercialization