Archives: Agenda

• Going beyond initial study objective with post-hoc analyses to assess additional effects of the study drug/treatment
• Utilizing multiple layers of data to tease out effects of the drug/treatment on subsets of study population
• Developing a strategy for generating a series of impactful publications with value to clinical, research, and patient communities

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

• 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