EU Clinical Trial Regulation Compliance

Challenge

In 2014, the European Medicines Agency (EMA) released the Clinical Trial Regulation (EU CTR) to harmonize the assessment and supervision processes for clinical trials throughout the EU. The regulation created new rules to enhance data transparency and increase safety standards, which directly affected numerous processes clinical-trial sponsors were using for trial registration and management.

Acquis’s client, a global pharmaceutical and medical device manufacturer, needed to initiate a cross-functional project to assess all aspects of its clinical-trial management and disclosure processes. Furthermore, the client needed to implement all necessary changes to fully comply with regulation prior to the 2019 deadline.

Approach: Think + Do

Acquis facilitated the creation of a formal Project Management Organization (PMO) sponsored by the client’s regulatory and compliance functions.

Acquis then established a project strategy, outlining a phased approach, which included a gap analysis to map differences between the existing directive and new regulation, a current-state analysis to derive an end-to-end view of the value chain, an impact assessment to capture all procedure, system, and organizational effects, and a future-state design to formalize the future-state roadmap with an implementation of all required changes to system, process, procedure, and organization.

Results

Acquis successfully managed this initiative by forming a series of cross-functional task forces and effectively leveraging the client’s subject matter experts across internal functional groups. The project remains on track and within budget, with all future-state changes to be implemented in time for the 2019 regulation deadline.