Impact Story

Managing Compliance: New EudraCT Regulation

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Program & Project Management

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Client Profile
Multinational Pharmaceutical Company
Industry
Life Sciences
Challenge
Revisions to the EudraCT legislation, released by the European Medicines Agency (EMA) in July 2014, now requires clinical trial sponsors to disclose trial results to the EudraCT database. The client was compliant with the previous registration requirements, and needed to address the new results disclosure requirements, retrospectively and prospectively. There were gaps in the client’s understanding of the regulation change and impacts to their organization to come to a compliant state.
Approach: Think + Do
Acquis proposed an end to end approach to address the legislation changes. We worked with leaders cross-functionally to gain clarity on the requirements, develop a plan to meet the aggressive EMA timelines, manage and prepare for impacts to the organization, and confirm resources were in place to ensure compliance. Activities included:
• Educating the organization on the legislation change
• Data identification and analysis
• 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 timeframe
• Prevented the client from realizing 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 their compliance risk level
• Trained the client teams on the prospective process, allowing for ongoing management and continued compliance
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