GCP QA SERVICES
CRQA can do independent QA for you by conducting audits of clinical trial investigator sites and sponsor clinical operations, to ensure compliance with Good Clinical Practice (ICH-GCP), FDA and local regulatory standards. We have the following to offer you:
Site, IRB/IEC, Document Audits, Vendor, CRO ( Phase I and/or BA/BE units)
Vendor evaluation, Data Management, Investigational Product Management, Biological Samples Management, Ethics Management, Monitoring.
DATA MANAGEMENT AUDITS
Database Audits, CDM plan, Document audit, System audits, SOP development, system and software validation to verify that the computerized system is validated according to regulatory requirements such as 21 CFR part 11.
AUDIT OF ESSENTIAL DOCUMENTS
Protocol, IB, CRF, ICD, Clinical Report Audits against client SOPs and ICH GCP requirements.
Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates-audits of database in comparison to reports/submissions to RA or other governmental authorities At the end of the audit, we would provide a comprehensive audit report to the client along with the audit certificate. The audit report would be discussed in detail with the client, corrective actions and preventive actions would be proposed to bridge the gaps and training to the personnel would be provided if required to prevent recurrences.
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