How Do You Mitigate The Risks To Patient Safety And Data Integrity In Virtual Clinical Trials?

A | AN ORGANIZED RFP PROCESS, vendor qualification/certification, and routine audits are core elements of managing a CRO relationship. The CRO self-attestation of their procedures is not enough; a pharma company needs to be much more diligent in its selection process.

After a partner is selected, another level of rigor needs to be installed. One of the strategies we deployed is a two-level management model. The joint working team is empowered with the execution of the program. A senior steering committee is also established to provide oversight and addresses high-level concerns, including data quality and security. Another important strategy is to limit the access inside of both the sponsor and the CRO to patient-level data.

AL ALTOMARI is chairman and CEO of Agile Therapeutics and a member of the company’s board of directors.