Experience

The QAS team has qualified expertise in performing worldwide Good Clinical Practice (GCP) auditing at Trial Centers, Laboratories, Sponsors and Clinical Research Organizations (CROs).

Successful development projects depend upon an understanding of the nuances of Good Clinical Practice (GCP) interpretations. At QAS, we have diverse and extensive knowledge of interpretations as a result of having worked with many sponsors of clinical research, law firms and the FDA. Furthermore, as QAS auditors monitor agency trends, we continually offer advanced GCP courses to our industry colleagues.

Domestic & International Audits:

Our auditors have expertise in individual country requirements as well as FDA clinical research requirements. Senior Quality Assurance Auditors are highly trained on FDA regulations and ICH guidelines to conduct intensive, professional audits.

QAS approaches international audits by teaming a seasoned Senior Quality Assurance Auditor with a trained medical professional with fluency in the Trial Center’s language in non-English and non-Spanish speaking countries. This approach provides a thorough medical evaluation of the clinical trial documents guided by the experienced Senior Quality Assurance Auditor’s assessment of the Trial Center’s adherence to regulatory requirements and international guidelines.

Audit Planning:

At QAS, we recommend conducting audits early in the clinical stages of development to detect deterioration in trial center performance due to staff and CRA turnover, loss of interest and enrollment pressures. We identify systematic problems in the conduct of your study, such as misinterpretation of protocols, lab procedures and efficacy assessments.

Data Trend Analysis:

QAS audits are not limited to the discovery of human error. Our expertise helps you find systematic errors and implement systems to prevent recurrence. QAS auditors are skilled at performing state-of-the-art Data Trend Analysis to detect clinical research fraud and misconduct. Having QAS audit your study results in early intervention and promotes effective corrective action that prevents delays and added expenses to your clinical program.

Training:

Has instructed more than 100 GCP and auditor training seminars and has presented at numerous industry conferences on GCP topics for the biologics, biotechnology, medical device and pharmaceutical industries.

Expert Testimony:

Has supplied expert and discovery witness services and testimony to corporate and outside legal counsels.

QAS Teamwork:

Our QA personnel are accustomed to working as a team with your organization. We encourage our clients to join our auditing team to maintain strong communication between the Trial Center, Clinical Research Organization (CRO) and Sponsor.

Click here to view Mr. Renaud's CV (PDF Format)