GxP Audits
Domestic and International Clinical Research Study GCP Audits
Established audit program to ensure that Sponsors are in compliance with FDA 21CFR312 and 812, ISO14155, ICH E6 – International Congress on Harmonization Guidance, Japan J-GCP, China NMPA/NHC and other government regulatory authority regulations and guidelines. In addition, audit program is designed to ensure compliance to specific company Standard Operating Procedure (SOP) requirements.
Clinical Supplier Audits: Contract Research Organizations (CRO) and Data Management and Biometrics Service Providers
Established audit program to ensure compliance to GxP requirements for sponsor’s pre-qualification consideration for adherence to regulatory, contracting company and supplier requirements. Audits of Investigational Review Boards (IRBs) and Laboratories are also offered.
Clinical Investigator and Sponsor-Investigator Audits
Established Investigator Site audit program to ensure compliance with 21CFR312 and 812, ISO14155, ICH E6 and other government regulatory authority regulations and guidelines, in addition to adherence to specific Investigator Site IRB and Standard Operating Procedure (SOP) requirements.
System and Process Audits
Conduct Mock-FDA BIMO audits, targeted ISO 14155 and ICH E6 audits with a focus on, but not limited to the following areas of clinical operations, clinical project management, monitoring, data management, (e)TMF, biostatistics, medical writing, device accountability, safety reporting, protocol deviations, and sponsor training.