In the second part of our discussion, Edye Edens speaks with subject matter expert Helen Maurer about integrating quality management into clinical trial contracts. While contracts often cover legal aspects like termination and jurisdiction, they frequently lack clear quality management plans. Helen emphasizes the importance of defining responsibilities, risk levels, and monitoring expectations upfront to avoid confusion and compliance issues later.

Key takeaways:

• Contracts should outline quality expectations beyond general regulatory compliance.
• A quality management plan should be a living document, adaptable as the trial progresses.
• Budgets must align with quality requirements to ensure proper execution.
• Negotiations often meet resistance when defining specifics, but clear planning prevents future disputes.

By embedding quality management into contracts and budgets, research teams can set clear expectations, improve compliance, and avoid costly surprises down the line.

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