We are a group of individuals who have had extensive years of experience in the federal government in regulatory science and publicly funded research, and collaborative partnerships with industry and CROs. We have also worked with major pharmaceutical drug companies and CROs in drug safety & pharmacovigilance for products in development, and products already approved but are under investigations for optimizing use and treatment paradigms. Our primary goal is to be highly effective in crafting solutions that would result in bringing evidence-based treatments which are safe and effective to people in need globally. We have over 20 years of expert experience in Drug Safety & Pharmacovigilance; from protocol safety to all aspects of safety data collection, expedited reporting and review, to safety monitoring. On occasion, we can serve as FDA expert witnesses, or provide contact referrals for such services.
A consulting agreement is necessary prior to the onset of any work. The scope and nature of the work will be outlined in the consulting agreement. Mutual confidentiality agreements are required prior to discussions of any and all proprietary information.
Our President: Ling Chin, MD, MPH, FACPM
Dr. Chin holds a Doctor of Medicine from the George Washington University, a Master’s in Public Health from the Johns Hopkins Bloomberg School of Public Health, and a Bachelor of Arts from Smith College. She had internal medicine training with a focus in primary care, and completed her residency in preventive medicine at Johns Hopkins. She is board-certified in Preventive Medicine and is a Fellow of the American College of Preventive Medicine.
Dr. Chin has spent the last 22 years with the federal government, in the Department of Health & Human Services, at FDA (Food and Drug Administration) and NIH (National Institutes of Health). She has extensive experience in clinical trials drug development; as an FDA medical reviewer, NIH program director & medical monitor, and lastly as the head of safety and pharmacovigilance for all of NIAID/DAIDS-supported clinical trials. She founded GDU Clinical Trials Consulting, LLC in 2012, with her broad experience in protocol development, protocol implementation, the lifecycle approach to drug safety in clinical development including safety monitoring, medical review and sign-off on adverse events, as well as oversight and hands-on experience with human subjects’ protection, clinical trial operations, safety data acquisition, review & reporting; across many therapeutic areas.
She contributed significantly to the development of Rx-to-OTC switch products, pushing the envelope for candidates eligible for consideration for OTC marketing, including guidances on Actual Use Studies and Label Comprehension Studies, as well as class labeling for vaginal microbicides. She was primarily responsible for the switch of several products and product categories such as: nicotine replacement therapies, vaginal antifungals, antacid reducers, cholesterol-lowering resins, treatment for benign prostatic hypertrophy, and a hair regrowth product. She was also involved as the primary medical officer for the OTC Monograph review for vaginal contraceptives, douche products, botanicals, etc.
In setting out to establish GDU Clinical Trials Consulting, Dr. Chin is very comfortable with meeting new people, coming to grasp with new development programs, strategic capacity & team building for targeted objectives, while respecting legacy processes, in the context of competing resource challenges & constraints. She came from an environment of working with interdisciplinary teams, within and across agencies, academic institutions, professional organizations, pharmaceutical companies and contract research organizations, always meeting project targets in a timely manner. In her spare time, she volunteers at a community free health clinic.