TRI conducts comprehensive, systematic, and independent audits of your Clinical Research sites, systems and databases, vendors and contractors’ qualifications, and Manufacturing/Laboratory processes, for quality improvement purposes and compliance with GxP – including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Goof Laboratory Practice (GLP) - and FDA regulations.
Our Certified Quality Auditors (CQAs) audit facilities, data and systems, and a wide-range of Clinical, Manufacturing, and Laboratory procedures by performing in-depth inspections and leading detailed staff interviews. We verify that monitoring is effective and certify that the research group performs according to expectations: in a fashion that promote patient’s safety, clinical data’s integrity, strict adherence to the protocol and Standard Operating procedures (SOPs), and compliance with regional and international regulations. Prior the audit, our highly trained and detail-oriented auditors customize your audit taking into consideration its critical aspects and the triggering reasons, prepare a comprehensive audit plan in accordance with regional inspection requirements, and define audit criteria to ensure efficiency and excellence.
During the audit of research sites, TRI collects and verifies information on drug dispensing and returns, patient records and source documents, informed consent forms and CRFs, monitor’s visits and adverse events documentation for instance. After completion of the audit, our CQAs ensure that the audited group understands the significance of the findings- that are reported in three categories: critical, major, and minor findings – and assist you in the design of an action plan composed of targeted corrective actions.
- Auditing Services
- Clinical Research Sites
- Vendor Qualification