CRO

Situation: High-Quality CRO has received a study from BioTropical, a mid-sized pharma company. The sponsor wants them to do the data management, including CRFs, database and querying, and the monitoring. The sponsor has not provided specifications, preferring that High-Quality use its best practices, which include DLPs.

Implementation: High-Quality reviews the protocol, pulls the appropriate Core DLPs from their library, and calls Kestrel to get the DLPs to cover the efficacy data. After minor configuration to address study-specific requirements, High-Quality is quickly able to produce draft CRFs, a database structure, data review and edit check specifications and monitoring guidelines, all of which are internally consistent. .

• Return to examples