February 10, 2015 | Register Today to Reserve Your Space!
This webinar will discuss the techniques that Good Clinical Practice (GCP) and those that FDA inspectors may employ to detect fraud. While fraud in clinical trials is rare, Precision will discuss the methodologies and techniques that sponsors need to be aware of to uncover fraud. Further, Precision will explore additional key sponsor responsibilities such as ensuring protocols are adhered to during enrollmentand certifying the data recorded is an accurate representation of that generated, all of which should be addressed through monitoring.
- Understand the difference between surreptitious behavior and sloppiness.
- How an inspector may "pull threads" to uncover trends in data recording anomalies.
- How to use monitoring as a means to ensure the integrity and veracity of clinical data.
- Statistical approaches that have been used to evaluate clinical data to uncover fraud.
Charles G. Thornton, M.B.A., Ph.D.
Director, In Vitro Diagnostics ∓ Quality
Precision for Medicine
Dr. Thornton has over 25 years of industry and FDA experience, including extensive experience in in vitro diagnostics. He has designed and implemented Laboratory Developed Tests (LTDs) for the clinical laboratory, developed Good Clinical Practice quality systems for manufacturers, and designed, implemented, and managed clinical trials to generate data for regulatory submissions. Dr. Thornton previously served as a Scientific Reviewer within FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), and as a Reviewer within FDA’s Office of Compliance (OC), Division of Bioresearch Monitoring (BIMO).
Dr. Thornton received a BS in Biochemistry from the State University of New York at Stony Brook, an MBA from George Washington University, and a PhD in Biochemistry and Molecular Biology from Case Western Reserve University.
Kennon Daniels, Ph.D.
Senior Consultant, In Vitro Diagnostics Regulatory Affairs
Translational and Regulatory Sciences
Precision for Medicine
Dr. Daniels has over 11 years of R&D and US Regulatory Affairs experience with in vitro diagnostic (IVD), medical device and pharmaceutical products. She has extensive expertise with IVDs and specializes in the development of regulatory strategies and submissions for a wide range of IVD assays (>30 products) including assays for oncology, genetic disorders, women’s health issues, cardiac biomarkers, infectious diseases, microbes, sepsis and diabetes. She is also responsible for the design of analytical and clinical protocols for the performance validation of these IVD assays to generate data for the regulatory submissions. Dr. Daniels is skilled in serving as the client representative during face to face meetings and teleconferences with FDA (CDER/CBER/CDRH/OIR).
Dr. Daniels received a BS in Biology from Mary Baldwin College and her Ph.D. in Human Genetics from Virginia Commonwealth University.
Cost: No cost!
Schedule conflict? Register now and you'll receive a copy of the recording.
You may also be interested in registering for these other Precision for Medicine webinars:
September 30: Good Clinical Practices and Conducting Effective Clinical Trials for IVDs in the US
January 27: Bridging Studies for US IVDs and CDx
February 24: FDA Perspective on IVD Clinical Trial Descriptions, Data Analyses, and Data Presentations in FDA Submissions