Good Clinical Practice (GCP)
Good Clinical Practice (GCP)
- Investigator Site Audits: Our experienced auditors conduct routine, directed, and for-cause audits of investigator sites. Through meticulous assessments, we identify areas for improvement and verify the adherence of site practices to GCP standards.
- Study/System Audits: We offer comprehensive audits of Phase I units/studies, Bioavailability (BA)/Bioequivalence (BE) studies, CROs, and sponsors. Our audits evaluate the compliance and performance of these entities, ensuring the reliability and accuracy of study data.
- Mock Inspections: In preparation for regulatory inspections, we conduct mock inspections of sites, CROs, and sponsors. Our tailored programs include inspection readiness activities, equipping organizations with the knowledge and tools needed to excel during actual inspections.