Clinical Operations & Trial Supply Forum

Opening Words

• Host / Conference Chairs
• The New Era of Integrated Trial Execution: Why Supply & Operations Must Converge

The Connected Clinical Trial: Aligning Operations & Supply to Accelerate Patient Delivery

• Where operational and supply-chain decisions intersect
• How enrollment, protocol changes and site performance impact supply
• Building one connected approach from study start-up to patient dosing

Reducing Site Burden: Simplifying the Clinical Trial Operating Model

• Reducing administrative workload
• Streamlining processes across sponsors, CROs and sites
• Using technology without adding more complexity

Recruitment & Retention: Turning Enrollment Challenges into Predictable Trial Execution

• Improving patient identification and screening
• Managing enrollment variability
• Connecting recruitment forecasts with operational planning

Barriers to Implementing AI and Digital Tools in Trials

• How do sponsors ensure data privacy and security?
• What operational challenges arise in global implementations?
• How do we validate AI models to satisfy regulators and investigators?

Building a Predictable Clinical Supply Chain: From Forecasting to Final-Mile Delivery

• Improving demand and inventory forecasting
• Managing manufacturing, packaging and distribution timelines
• Increasing supply visibility across the trial

IRT/RTSM & Real-Time Supply Visibility: Smarter Resupply, Less Waste

• Using real-time enrollment and inventory data
• Optimizing site-level resupply
• Connecting IRT/RTSM with supply forecasting

Breaking Down the Silos: Should Clinical Operations & Supply Teams Plan Together?

• Where communication breaks down between functions
• Creating shared KPIs and accountability
• Building an integrated operating model across Clinical Ops, Supply, CROs and vendors

Cold Chain & Specialty Logistics: Protecting the Product All the Way to the Patient

• Managing temperature-sensitive products
• Preventing excursions and product loss
• Improving shipment monitoring and contingency planning

The 2027 Clinical Trial Execution: One Strategy, One Supply Chain, One Patient Journey

Discussion:

• What should Clinical Operations stop doing?
• Where can Supply Chain become more predictive?
• How can sites experience less burden?
• Which technologies can genuinely improve execution?
• What should sponsors change before their next trial?