Archives: Agenda

• Exploring practical strategies for outsourcing CDM functions to support successful clinical study delivery
• Establishing clear governance and communication models with vendors to enhance efficiency and maintain data quality and oversight
• Leveraging vendor capabilities effectively while sticking to budget and without compromising operational control

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• Where RWD/RWE fits in the evidence lifecycle: Understand use cases before trial, during trial, and after trial.
• Role of RWD in trial execution
• Benefits of RWD/RWE in strengthening submissions

• Automate the routine: Apply intelligent, rules-based automation against imported study data and bi-directional workflows to streamline the opening and closing of issues and queries.
• Focus on what matters: Reduce manual effort and enable data management teams to focus their expertise on critical data, exceptions, and decisions that require human judgment.
• Drive impact today: See how Integrated Data Review Plan (IDRP) capabilities work together with this automation engine to speed the path from plan to action – for a more proactive, efficient, and scalable data review process that teams can put to work today.

• Discuss the concept of reimbursable file objectives incremental to regulatory file objectives guiding clinical program development and execution
• Understand how the market access function is collaborating much more frequently with clinical development teams and why this trend is accelerating
• Share examples of what ‘good looks like’ and some of the pitfalls, challenges with collaboration between market access and clinical development

Concept: This is the practical second half of the workshop, where attendees use real examples to test and refine the trend forecasting framework. Working through guided scenarios, participants will identify signals and translate outputs into concrete decisions.

Takeaway: Attendees will leave having validated the framework through hands-on practice, with a completed sample forecast and a reusable template they can take back to apply to their own clinical data management processes

Traditional clinical trial execution suffers from costly efficiency losses and heavy monitoring burdens due to manual data transcription. This session introduces a simplified, integration-free EHR-to-EDC approach that streamlines the clinical data flow. Attendees will discover how this solution enables universal site adoption, cuts transcription time by up to 80%, and achieves near 100% data accuracy at the point of entry.

These collaborative team-building exercises, provide a focused opportunity to work alongside your peers to tackle common clinical data management challenges and develop practical, actionable solutions. Each session begins with a concise 10-minute problem statement presented by the session lead, setting the context and clarifying the key question to solve.

Participants then move into a 30-minute “whiteboard” working session, where each table co-develops a draft framework or potential solution to the challenge. To close, each table briefly summarizes its proposed approach, allowing the wider group to compare perspectives and walk away with multiple actionable solution pathways.