Impact Story

EU Clinical Trial Regulation Compliance

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Impact Story

Managing Compliance: EudraCT Regulation

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Client Profile
A global pharmaceutical and medical device manufacturer
Industry
Life Sciences
Challenge
In response to the European Medicines Agency’s (EMA) release of Clinical Trial Regulation, Acquis helped this client assess its clinical trial management and disclosure processes and implement changes to comply fully with regulation prior to the expected 2019* deadline.

*The EU Clinical Trial Regulation will come into application in 2019 [EMA publication, June 2017].
Approach: Think + Do
Acquis first helped create a formal Project Management Organization (PMO) with the client’s regulatory and compliance functions to oversee the department’s pending series of projects. Acquis then established a project strategy and outlined a phased approach for the implementation of the regulation. Key project deliverables included a gap analysis, current state analysis, impact assessment, future-state design, and implementation of the resulting changes.
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.
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