Abstract

A modular survey for evaluating contract research organization (CRO) performance is described. Ten of the 11 modules address a specific area of CRO performance, such as project management, monitoring, and data handling; the eleventh module addresses general CRO performance. Each module consists of positive statements to be checked under one of four categories of response: strongly agree, inclined to agree, inclined to disagree, strongly disagree. The survey is designed to allow quantitative evaluation. Sponsors’ employees who closely interact with CROs can use the survey to compare among CROs or to measure a CRO’s performance from project to project. In contrast to open exchanges of opinion among reviewers of CRO performance, the results of this modular survey showed less variability of opinion among the same reviewers. This standardized approach to evaluating CRO performance is an invaluable guide lo a sound decision as to which CRO to choose.

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