Systems and procedures that assure the quality of every aspect of the trial should be implemented
The Principles of ICH GCP #13
Whether you are a sponsor, investigator or contractor - everyone involved in clinical trials is required to do everything they can to ensure the quality of all aspects of clinical trials.
This is a requirement that TMQA can help you to understand and comply with.
Our experienced GCP experts can provide advice and training or indeed perform the GCP audits necessary to ensure you meet this requirement in trials that you're are performing – or others are performing on your behalf.
TMQA’s Clinical (GCP) QA Services
Preparing for the trial
- Vendor selection inspections
- QMS implementation consultancy and reviews
- Protocol, CRF and informed consent audits
Performing the trial
- Investigator site audits
- Vendor oversight inspections
- Trial Master File audits
Reviewing the outputs
- Data management and statistical analysis audits
- Clinical study reports audits
- Marketing Authorisation Application / Common Technical Document audits
Regulatory Authority Review
- Review of your trial documentation
- Interview readiness training
- Mock inspections of your systems and procedures
Our experience covers all phases of trials from phase I to phase IV. The TMQA team includes experts in IMP management and clinical laboratories.