Lack of distinction, poor understanding, and misuse of the terms Full-Service Outsourcing (FSO) and Functional Service Provider (FSP) ultimately fail to provide Clinical Research Organizations (CROs) with meaningful and actionable insight to inform strategic decision-making and continuous improvement.
Today, biopharmaceutical companies collect vast operating data to inform, predict, and ultimately optimize clinical trial performance. However, without a clear understanding of differentiated outsourcing models, this data offers insufficient insight into the contribution and comparative value of a model or combination of models. Also, as operating models continue to evolve, the outsourcing models have not adapted during the same time.
With a lack of differentiation between FSO and FSP approaches, it is critical for CROs and sponsor companies to standardize the definitions of sourcing models in use. Universal definitions ensure a common understanding between partners and the industry concerning roles, responsibilities, and accountabilities. Consistency in the descriptions used by the industry to characterize work is also critical for establishing industry-wide recognition. It also facilitates the acceptance of benchmarks that enable more meaningful and reasonable comparisons of the effectiveness of sourcing models across the life of a development project.
A standardized CRO sourcing model terminology will ultimately lead to higher quality work and improved patient outcomes.
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