Clinical Operations & Trial Supply Forum

Host / Conference Chairs

The New Era of Integrated Trial Execution: Why Supply & Operations Must Converge

Implementing ICH E6(R3) in Clinical Operations: Strengthening Digital Data Integrity and Risk-Based Quality Management

• Aligning operations with ICH E6(R3)
• Ensuring digital data integrity
• Applying risk-based quality management

Accelerating Trial Start-Up: Removing Bottlenecks from Site Selection to First Patient In

• Aligning operations with ICH E6(R3)
• Faster site feasibility and selection
• Streamlining contracts, budgets and activation
• Improving sponsor–CRO–site coordination

Solving New Jersey’s Patient Recruitment & Retention Challenge

• Improving patient identification and pre-screening
• Reaching diverse and underserved patient populations
• Reducing screen failures and improving retention

Reducing Site Burden: Building More Efficient Clinical Trial Operations

• Streamlining site documentation and workflows
• Addressing coordinator workload and resource constraints
• Creating stronger sponsor–CRO–site partnerships

AI in Clinical Operations: Moving from Innovation to Measurable Trial Efficiency

• Applying AI to recruitment, monitoring and data management
• Automating repetitive operational activities
• Moving from AI pilots to scalable clinical workflows

Building New Jersey’s Clinical Research Workforce for the Next Generation of Trials

• Recruiting and retaining skilled clinical research professionals
• Closing gaps in clinical research training and competencies
• Developing sustainable workforce and onboarding models

Clinical Supply Forecasting: Connecting Enrollment Reality with Supply Planning

• Improving enrollment-based demand forecasting
• Managing changing patient numbers and protocol amendments
• Reducing stock-outs, over-supply and product waste

Cold Chain & Temperature-Sensitive Supply: Protecting Investigational Products from Depot to Patient

• Managing temperature-controlled shipments
• Preventing excursions and product loss
• Improving shipment monitoring and contingency planning

IRT/RTSM & Real-Time Inventory: Turning Clinical Data into Smarter Supply Decisions

• Improving visibility of inventory across sites
• Optimizing resupply and drug allocation
• Connecting IRT/RTSM data with enrollment forecasting

The New Era of Integrated Trial Execution: Why Supply & Operations Must Converge

Summary of main insights