Governance Structure
A case on how we developed a holistic CRO governance framework and issue escalation process to not have the unprecedented growth phase of our client affect their clinical trials.
Client Profile
Company Name: Non-disclosed for clients privacy policy
Company type: Renowned Contract Research Organization
Company Size: large enterprise
Industry: Clinical Research
Location: HQ in the U.S., operating world wide
Client Challenge
A drug development company focused on the co-development and financing of pharmaceutical has been experiencing unprecedented growth.
The company partnered with our team to design and develop a holistic CRO-supplier governance framework and issue escalation process as template for all the clinical trials.
Client’s Words
“Just wanted to acknowledge that the materials look tremendous and I think the report really tells a cohesive story now so that they almost standalone. I am very pleased with where we are with this. Thanks very much..”
Vice President of Clinical Development
Seuss+ Approach
Three phases to success
Phase 1 – Assessment
- A combination of SOPs review and Gap Analysis on existing documentation, escalation processes, vendor evaluation etc.
Phase 2 – Development of new practices
- The development of new governance practice and issue escalation process and demos of technology platform.
Phase 3 – Launch Program
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Launch program to leading CRO and individual suppliers so that they are integrated into the program
Our Impact
Increased efficiencies and compliance
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CRO-Supplier Governance has decreased time in meetings and increased the oversight efficiency and consistency in the programme across all suppliers.
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Sponsor – CRO – suppliers have over-achieved critical milestones.
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Company is audit ready and now compliant to meet current and future regulatory expectations with ICH GCP E6 (R2).
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