On-Demand Webinar

The timelines for clinical trials remain under pressure due to the complexity of study build processes, the cost of enablement, and a one-size-fits-all approach that does not scale well based on the phase and complexity of the study. With the changing regulatory requirements under ICH E6(R3), it is also necessary for sponsors to apply Quality by Design (QbD) and Critical-to-Quality (CtQ) principles early, from study design and build.

The session will cover how Medidata Designer enables a single build for EDC, eCOA, RTSM, Consent, Imaging, and Clinical Data Studio to help manage complexity while ensuring consistency across systems. An introduction to AI-assisted study build, change impact awareness, and version control will demonstrate how organizations can deliver studies faster, more affordably, and with better quality without adding to the operational burden.

What You’ll Learn

• How to move from protocol to study go-live faster using a single, unified build platform
• How to simplify complex study designs while aligning early with ICH E6(R3), QbD, and CtQ expectations
• How automation and reuse can cut build effort, reduce risk, and scale efficiently across your study portfolio