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.
“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
Step 1 – SOPs Review
Step 2 – Gap Analysis on existing documentation, escalation processes, vendor evaluation system, meeting and governance structure
Step 3 – Development of new governance practice and issue escalation process
Step 4 – Market research and demos of technology platforms
Step 5 – Launch program to leading CRO and individual suppliers so that they are integrated into the program
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).