Sponsor, CRO, and Vendor Audits

QC2 offers the following sponsor, contract research organization (CRO), and vendor audits:

Clinical Operations Audits

QC2 conducts audit of sponsor and CRO project management, monitoring, medical writing, regulatory affairs, safety oversight and reporting, medical monitoring, and quality assurance systems and procedures to assess compliance with 21 CFR Parts 50, 54, 56, 312, and 820, ICH guidelines, protocol(s), and transfers of obligations.

Data Management and Biostatistics Audits

QC2 performs audits of data management and biostatistics systems to assess compliance with applicable FDA regulations and guidelines, as listed in 21 CFR Parts 11 and 312, Guidance for Industry: Computerized Systems Used in Clinical Investigations (May 2007), ICH GCPs, good programming standards, IEEE Software Development Life Cycle (SDLC) principles (as applicable), and current industry concepts in computerized system validation.

IVRS, IWRS, and IXRS Audits

QC2 conducts audits of interactive voice response (IVRS), interactive web response (IWRS), and multi-modal (IXRS) system vendors to assess compliance with applicable FDA regulations, including 21 CFR Parts 11 and 312, the ICH GCPs, Annex 11 to the EU GMP Guide as applicable, FDA Guidance for Industry, Computerized Systems Used in Clinical Investigations (May 2007), good programming standards, and current industry concepts in computerized system validation.

Central Reading Center Audits

QC2 performs audits of central reading and imaging centers (e.g., ECG, Holter, CT, X-ray, spirometry, angiograms, etc.) to assess compliance with applicable FDA regulations and guidelines, including 21 CFR Parts 11 and 312, Guidance for Industry: Computerized Systems Used in Clinical Investigations (May 2007), ICH GCPs, good programming standards, and current industry concepts in computerized system validation.

Electronic Data Capture (EDC) and Remote Data Capture (RDC) Audits

QC2 conducts audits of EDC systems to assess compliance with applicable FDA regulations and guidelines, including 21 CFR Parts 11 and 312, Guidance for Industry: Computerized Systems Used in Clinical Investigations (May 2007), the ICH GCPs, good programming standards, IEEE Software Development Life Cycle (SDLC) principles (as applicable), and current industry concepts in computerized system validation.

Site Management Organization (SMO) Audits

QC2 performs audits of site management organization (SMO) systems and procedures to assess compliance with 21 CFR Parts 50, 54, 56, and 312, ICH Guidelines (as applicable), protocol, and transfers of obligations documentation.

Safety Reporting Audits

QC2 conducts audits of pre- and post-marketing safety reporting systems and procedures to ensure compliance with regulatory authority requirements for expedited and periodic reporting including as applicable 21 CFR Parts 312.32, 314.80, and 600.80, FDA, ICH and EMA guidances, ex-US regulatory authority requirements, and best practices.

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development, audit scheduling, conduct, and reporting, and audit follow-up services (e.g., review of audit responses).  We conduct both general qualification audits and in-study audits. Many of our audits can be conducted remotely, helping our clients to maintain their audit programs during this unprecedented time.