13:45 – 15:45 OPEN WORKSHOP 4: The End of Fragmented Clinical Data: A New Model for Trial Decision-Making (IN-PERSON ONLY)
INSTRUCTORS:
Abhishek Chatterjee, Group Vice President, Product & Insights & Site Head, Product, H1
Guillaume Carbonneau, Senior Vice President, Clinical Strategy & Solution Design, Product, H1Historically, clinical development has been built on disconnected data sources and processes. With the adoption of AI, a new model is emerging. H1 will share how sponsors can unify operational and clinical data into a single trusted foundation, resolve it against global investigator intelligence, and layer on configurable analytics and AI agents that power decisions across site selection, PI strategy, timelines, and trial economics.
Drawing on a real-world partnership with Novo Nordisk, we'll explore what it takes to unify fragmented data, how AI agents are beginning to automate work that once took weeks, and what clinical teams need to do now to build this kind of foundation. Attendees will leave with a practical framework for modernizing their clinical intelligence infrastructure, including where gaps commonly exist and how industry leaders are addressing them.
15:30 – 16:45 OPEN WORKSHOP 2: AI, Digital Twins, and Connected Insights: The Future of Clinical Trials is Here (IN-PERSON ONLY)
INSTRUCTORS:
Rohan Fernando, Head of R&D, ZS Associates
Christian Sorensen, Senior Director, Clinical Data Products & Analytics, Novo Nordisk
Sowyma Srinivasan, Principal, ZS
Emilie Tyas, Associate Principal, R&D and Drug Development, ZS
Reimagining how trials are designed, run, and experienced. Clinical development is at a tipping point. After a decade of steady digitisation, the convergence of multimodal data, agentic AI, digital twins, and growing regulatory openness has finally made a fundamentally different operating model possible. Trials are poised to shift from slow, fragmented, and linear to connected, intelligent, and continuous, with meaningful gains in cost, speed, and the probability of success. In this 75-minute interactive workshop, ZS will share a bold vision for the future of clinical trials, grounded in four building blocks: R&D Mission Control, the In Silico Slingshot, the Clinical Trial Biosphere, and Data at the Speed of Light. We will then open the floor for structured dialogue with peers on adoption barriers, talent implications, and the first practical moves clinical development leaders should make now. Join us to pressure-test the future of clinical trials with the people building it.
17:00 – 18:30 OPEN WORKSHOP 3: ICH E6(R3) in Practice: Redesigning Clinical Trial Execution, Quality, and Oversight (Sponsorship Opportunity Available) (IN-PERSON ONLY)
INSTRUCTOR:
Madeleine Whitehead, Process Excellence Leader, Product Development Quality Solutions, Roche Products Ltd.
With ICH E6(R3) now in effect, this workshop walks clinical research teams through the practical implications for oversight and quality management. From the rationale behind the revision through investigator oversight and digital compliance expectations, the session translates the new guidance into what it means for monitoring plans, quality management systems, and collaboration between sponsors, study partners, and sites. A case study exercise and open Q&A close out the session, giving attendees a chance to apply the framework to real-world scenarios.
- Ethical foundations and the historical evolution of GCP
- Building quality into protocols with Quality by Design (QbD) and Critical-to-Quality (CtQ) factors
- Tailoring monitoring intensity, data verification, and oversight proportionate to study risks
- Data governance and enforcing ALCOA+ standards
- Understanding the modernized R3 terminology shift
- Investigator oversight and responsibilities under R3 expectations
- Compliance in digital systems and remote consent
- Pragmatic trial execution