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 QAEarly StagePre-clinicalClinicalRegistrationMarket
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
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