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A global biopharmaceutical company discovered a set of market opportunities that necessitated acceleration of its plans to take a series of compounds into Stage II trials. Recognizing it lacked the manpower and operational infrastructure to manage the accelerated plan across three geographies, it elected to engage a contract research organization (CRO). With Everest Group’s assistance, the company captured the critical capabilities required to support the effort, and initiated a sourcing process to define the required services, evaluate the CRO’s capabilities, design a performance and payment regimen and facilitate final contracting negotiation and governance setup. The resulting solution accelerated the trial period by 25 percent and reduced the overall trial cost by 30 percent.
The biopharmaceutical company confronted a number of challenges:
Everest Group and the internal “Tiger” team worked with the broader organization to capture trial requirements across 18 functional areas, (e.g., site management, patient recruitment and retention, clinical monitoring, quality management and document management). In addition, they collaboratively developed the CRO RFPs, facilitated joint-solution workshops, designed customized service governance models and negotiated the final commercial and contractual terms.
Everest Group generated impact in four key areas. First, its focus on shareholder return enabled acceleration of a key clinical trial. Second, it challenged the organization to inclusively coordinate quality assurance activities with its CRO provider. Third, it demonstrated the economic and operational advantages of performance credit regimens that had been successfully leveraged in other industries. Finally, it helped the biopharmaceutical company create a repeatable sourcing process and services construct that could be used again to achieve the same accelerative effect for future trials.