Use our experience to improve your TMF management
If your TMF approach needs improvement, it might be time to get some help from Hedian. Whatever issue you are facing, our years of TMF experience will provide guidance and clarity.
Read on to find out how we can support you with TMF Governance and CRO Oversight.
Governance Frameworks
Best practice is to define clear TMF ownership, responsibilities and decision-making authority. This applies to sponsors, CROs and other vendors to ensure accountability throughout the trial lifecycle. Hedian can help you establish documented governance processes, escalation pathways and quality review mechanisms that support consistent oversight, compliance and inspection readiness.
TMF Oversight
The sponsor remains accountable for an outsourced TMF and requires risk based oversight approaches to maintain visibility. These approaches must focus on quality, completeness and compliance without duplicating CRO activities. Hedian can create structured oversight plans that define review frequency, reporting requirements and quality checks. These approaches are designed to align to study risk and complexity to meet ICH E6 requirements.
CRO TMF Performance Reviews
Periodic assessments of CRO TMF performance against agreed KPIs, quality standards, filing timelines and inspection readiness objectives is essential. Such approaches help to identify trends, root causes and improvement opportunities. Hedian can perform an independent review or an ongoing program of reviews to ensure your CRO is maintaining the TMF as required and to ensure issues are addressed before they become compliance risks.
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Get in touch
For more information about Hedian can help your TMFs and your business with their TMF Services, please get in touch.
We offer for a free no obligation initial meeting, please contact us.