Clinical Trial Governance & Vendor Oversight
At Seuss+ Life Science Consulting, we guide you through the intricate yet crucial steps of creating and implementing a governance and oversight framework tailored to your needs that sets the essential groundwork for a successful long-term relationship between you and your strategic sponsor-supplier.
Benefits of Clinical Trial Governance and Oversight
Our team can assist you in creating a governance framework for sponsor-supplier partnerships. We are here to make the process easier for you.
- Our approach involves utilizing data to make informed decisions for your clinical trial outsourcing.
- Tailored solutions and established processes ensure quality and compliance when outsourcing.
- Once you’ve successfully completed our Mock Audit process, you’ll be fully prepared for a genuine audit.
Oversight and governance—what to expect
Our team conducts a comprehensive evaluation of the required resources and existing materials from the sponsor or CRO team to provide a robust toolkit and governance framework for the senior sponsor-supplier core team.
Micro-management vs Oversight
Target Limited Resources Better
Vendor oversight is required by ICH-GCP to ensure sponsor accountability
Our team and clinical trial governance experts work closely with you to seamlessly integrate selected suppliers into your governance framework, ensuring comprehensive oversight of all aspects.
Internal Quality Checks (training record, TMF, data reviews, etc.)
Audits and Issue Logs.
Quarterly Status Update Reports for Key Performance Indicators.
Consider MSA, work orders, out of scope tasks, update meetings, and informal calls for project success.
Insightful Supplier Classification