Client Challenge Faced
A small biopharma company was expecting a large Change Order (CO) from it’s primary CRO on a Phase IIB global clinical program that was experiencing delays. The company had limited means by which to evaluate the CO, given a mix of performance issues and COVID-related delays in study start-up and recruitment, as well as cost overruns due to low initial estimates for investigator pass-through grants.
TriRadial Approach
- The TriRadial team of experienced SMEs performed a deep-dive root-cause analysis into the patient recruitment delays and cost over runs
- The team benchmarked investigator grants based on the site mix and our knowledge of current international rates in this therapeutic area
- Performed a cost impact analysis of increases only, to facilitate a rapid negotiation approach
- Revised the budgeting methodology used by the CRO to ensure transparency and to support negotiations
- Helped client prepare for negotiation and participated in actual negotiation meetings with vendor
Results
- Root cause analysis identified specific areas the needed to be addressed
- Cost Impact Analysis enabled a timely review and immediately evident identification of cost changes and reconciliation
- The team achieved a 33% reduction from originally proposed increases in Direct Fees
- The client’s study and management team received firsthand experience leading contracting and vendor negotiation practices
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