Institutional Review Boards Audits

The Institutional Review Board (IRB) has the responsibility and authority to observe directly ongoing research projects and the consent process, as well as conduct continuing review of the project, including audits of research records. 

On-site IRB audits are conducted to ensure the Board is composed and operates in accordance with regulatory requirements guarding and protecting human subjects participating in research.

We can assist the companies willing to outsource Clinical Sites Audits in the conduct of a Good Clinical Practice (GCP) audit at investigator site and in assessment of systemic compliance to GCP requirements and protocol.

We provide a full range of services, including the preparation, conduct, documentation and follow. Audits can also be performed in teams together with co-auditors from the client.