Managing Compliance: EudraCT Regulation

Challenge

Revisions to the EudraCT legislation, released by the European Medicines Agency (EMA) in July 2014, require clinical trial sponsors to disclose trial results to the EudraCT database. This client was compliant with the previous registration requirements, and needed to address the new disclosure requirements retrospectively and prospectively. There were gaps in the client’s understanding of the regulation change and how the organization would become compliant.

Approach: Think + Do

Acquis proposed an end-to-end approach to address the legislation changes and support the client with clinical trial disclosure and transparency. We worked with leaders cross-functionally to understand the requirements, develop a plan to meet the aggressive EMA timelines, manage and prepare for the effects on the organization, and ensure resources were in place to ensure compliance. Key activities Acquis performed included:

• Educating the organization about the legislation change
• Identifying and analyzing data
• Building roadmaps for retrospective and prospective disclosure
• Managing remediation activities

Results

• Implemented an approach that allowed for all required trials to be remediated within the specified time frame
• Protected the client from any ill-effects of non-compliance through proactive issue and risk management
• Developed a thorough report of project activities to aid in future remediation efforts
• Remediated existing data gaps, which improved the overall quality of company clinical trial data
• Provided senior management with confidence in its compliance risk level
• Trained the client teams on the prospective process, allowing for ongoing management and continued compliance