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.

Clinical Trial Sites Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

Early audits can identify systematic problems in the conduct of a clinical trial. Corrective actions will immediately contribute to project management success.

External audits offer more guarantees for independence from company’s procedures and operational units.
Studies, service providers and systems are audited against international and national standards, namely ICH GCP and the Clinical Trial Directive 2001/20/EC and GCP Directive 2005/28/EC and the relevant parts of the FDA CFR

QA INSIGHT  LTD.

an independent and experienced contract QA consultancy providing wide variety of Quality Assurance, auditing and training services for Medical Devices and Pharmaceutical Industries.