The $100 Million Question: Why Is Clinical Data Still Designed Last?

Despite representing only ~15% of trial costs, clinical data management underpins 100% of a trial’s credibility. Yet, in many organisations, data design is still treated as an afterthought — following protocol development, operational planning, and site activation. This misalignment creates inefficiencies, drives costly amendments, and undermines the quality-by-design principles that regulators such as EMA and FDA now demand.

This session will challenge the status quo and reframe the role of data managers in modern clinical research. With the implementation of ICH E6(R3) and the rise of digital tools — from structured protocol authoring and USDM-based workflows to automated database builds — data managers are shifting from being the “clean-up crew” to becoming architects of the entire data flow.

The presentation will highlight:

• Why starting with data is essential for efficient, credible, and patient-focused trials.
• How regulatory shifts and new technologies elevate the role of data managers.
• The opportunities for data managers to influence protocol design, data strategy, and even policy.
• A call to action: Data managers are not merely operational executors; they are the guardians of trust in clinical research.

By the end of this session, participants will leave inspired and empowered — ready to claim their seat at the table and help shape the future of clinical trials. Because while clinical operations may run the trial, it is data management that defines its legacy.