CRO Selection and Management

The decision matrix for the selection of a CRO requires careful definition of the service required and identification of associated critical factors e.g. cost, technology, quality, logistics and time-lines. In addition, significant advantage can be gained from experience with an extensive network of CROs and existing relationships. In the case of niche service providers or service providers with exclusive use of proprietary technologies, the options may be limited and require a proactive approach to ensure a successful collaboration. This is where the skills and broad experience of CMC consultants at Kinesis Pharma can be harnessed to serve the individual requirements of the sponsor and project.

A practical example: In CMC development, CROs are often employed for the purpose of analytical method development and validation for characterization and/or routine analysis including quality control/release testing. A single CRO may not be skilled in development, validation and routine analysis (in a suitable good practice quality environment). Analytical methods are often developed and validated before being transferred to a different CRO (or CMO) for routine analysis. This complex process requires management of the CROs and experience of the practical aspects of technology transfer.

Once CROs are selected, Kinesis Pharma can carefully manage all aspects of the relationships, this may include contract negotiations, (technical) design and monitoring, and reporting to agreed timelines.