Clinical Trial Compliance Quality Assurance
Covering all the bases gives you a clear path to approval.
Our team lead liaises with all relevant project stakeholders regarding any quality issues, study status and helping you with all aspects of the audit process. We support you throughout any and all of the following:
- Project audits
- Investigator files / site audits
- Trial master file audits
- Database audits
- Statistical report audits
- Clinical study report audits
- Regulatory submission audits
- Process audits
- Vendor audits
Helping you take action to get compliance quality assurance right.
Following the audit, we identify issues for the responsible parties to resolve at the project level. If we identify broader, systematic issues, we help you operationalize corrective action plans to resolve these issues.
Additional services include:
- Regulatory guidance and training on GCP
- Quality metrics for management reporting
- Investigator meeting support, e.g. presentations on GCP, common audit findings and handling regulatory inspections at sites
- Regulatory inspection support, e.g. hosting inspections or preparing investigator sites for inspections
- Standalone auditing service, including investigator brochures, protocols and informed consent forms (and amendments) and regulatory submission documents