Providing Sponsor Oversight for Medical Quality Assurance
Good Clinical Practice (GCP) guidelines require third-party oversight over clinical trials at every stage. ADRES has built a highly qualified, experienced medical QA team to perform this critical role during the clinical phase.
| Medical QA | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Build QA Systems Establish quality management systems required for clinical phases |  | ||||
| Prepare and Review Clinical Documents Review clinical study protocol, informed consent and investigator brochure Create and review study-specific plans | | ||||
| Qualification and periodic evaluation of service providers (including onsite/remote audits at CRO, IRT, drug supply, etc.) | | ||||
| Clinical sites Oversight Global GCP audits of clinical sites | | ||||
| Create Quality Agreements with service providers and clinical sites. Review and establishment quality agreements | | ||||
| Provide ongoing medical QA support remotely and/or at client’s offices | | ||||
| Lead and support GCP inspection readiness and risk assessment processes | | ||||
| User Acceptance Testing (UAT) Perform and oversee user acceptance testing for computerized systems | | ||||
| Periodic review and classification of protocol deviations | | ||||
| Investigate and review process deviations associated with clinical trials | | ||||
| Trial Master File (TMF)/ electronic TMF (eTMF) Periodic review of TMF/eTMF for completeness and accuracy with essential documents requirements | |
