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 

  • Launch program to leading CRO and individual suppliers so that they are integrated into the program

Our Impact

Increased efficiencies and compliance

  • CRO-Supplier Governance has decreased time in meetings and increased the oversight efficiency and consistency in the programme across all suppliers.

  • Sponsor – CRO – suppliers have over-achieved critical milestones.

  • Company is audit ready and now compliant to meet current and future regulatory expectations with ICH GCP E6 (R2).

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