Strategic partnership: the successful contract laboratory-sponsor relationship.

Contract laboratory. These two words often trigger a number of concerns for a sponsor, concerns that range from timing and cost considerations to issues of technical and regulatory capability. From a contract laboratory perspective, the best way to address these concerns is for the sponsor to consider the contract laboratory as a strategic partner, a provider of needed services. In many ways, the lab should function as an extension of the sponsor's own technology group. This partnership approach should foster effective communication so that the contract laboratory understands both the technical and regulatory objectives of the sponsor as well as any unique factors that could impact the study. A team approach will ensure an understanding of the role of each participant, approaches to be used in problem solving, and details of the sponsor/laboratory interaction, such as protocol input/development, technical updates/reviews, quality assurance audits, and final report format and approval process. This presentation will share perspectives from one contract laboratory on strategic partnerships for good science, with compliance, remembering that for the sponsor, the successful study is done on time, on budget, and is accepted by the agency.