Clinimetrics worldwide compliance and quality assurance team ensures compliance with standards of good clinical practice, good
laboratory practice and country specific regulations and guidelines.
Good Clinical Practice (GCP) Audits
We maintain a staff of experienced auditors that follow FDA and ICH regulations and guidelines to ensure consistent audits
across global trials. Internationally, many of our staff are multilingual, thereby ensuring continuity of communication across
borders. Our auditors work closely with each client to develop and implement audit plans that utilize and comply with the
client's Standard Operating Procedures (SOP).
- Preparation of essential document review guidelines
- Investigator site audits to verify the accuracy of the data being submitted to the sponsor and to ensure the site is complying with the protocol, regulations and guidelines
- Protocol and Informed Consent Form reviews for compliance to GCP and SOPs
- Database audits
- Final report audits
- Sponsor/monitor/CRO audits
- Institutional Review Board/Independent Ethics Committee audits
- Review of key deliverables (protocols, reports, datasets, etc.)
- Trials management center and database reconciliation
- Compliance and auditing services include vendor and site audits
- Preparation of investigators for regulatory authority audit
Good Laboratory Practice (GLP) Audits
- Protocol reviews
- FDA-mandated audits of in-life study procedures
- FDA-mandated final report audits
- Facility audits
Our Audit Record
- Many of the studies/sites we have managed have been audited by the Food and Drug Administration (FDA) or have been subjected to Good Clinical Practice (GCP) audits by our clients’ internal quality assurance staff
- No significant deficiencies in the areas of regulatory compliance, protocol compliance, drug accountability, or data integrity have been identified in any audit for studies managed by Clinimetrics
- Clinimetrics was contracted by FDA’s Center for Drug Evaluation and Research to perform GCP audits on several FDA-sponsored trials
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