Quality Assurance Consultancy supports organizations in conducting clinical studies for regulatory compliance.
Serving as third-party quality assurance (QA) auditors under the FDA and ICH GCP, our specialists serve as an independent review of clinical studies.We work on behalf of the sponsor or clinical research organization (CRO), providing the following services:
- CRO and clinical site qualification
- Clinical site study audits
- Investigators brochure (IB) audit
- Institutional review board (IRB) audit
- Source documents review/audits
- Database audits
- Bioanalytical data and report audits
- Trial master file review
- Clinical reports audits
