Heather Reynolds is a clinical operations and medical affairs consultant with over 20 years of experience supporting both sponsors and CROs in all phases of medical device and pharmaceutical clinical trials, from feasibility through study close-out. Her expertise includes clinical trial planning, execution, auditing, and oversight. Ms. Reynolds offers a wide range of services to support clinical trials, including: study site selection and qualification; clinical study documentation (monitoring and study plans, protocols, informed consent documents, case report forms, investigator brochures, training materials); CRO selection; EDC design and development; and clinical trial staff training. She also assists sponsors with development of clinical operations department SOPs, clinical trial project management, timelines, and budgets to ensure operational efficiency. Ms. Reynolds has worked on ophthalmic glaucoma, macular degeneration, cataract, and dry eye clinical trials as well as trials in neurology, endocrinology, gastroenterology, women’s health, oncology, cardiology, and infectious disease. In the area of medical affairs, she contributes to scientific communication through the preparation of abstracts, posters, and manuscripts. Ms. Reynolds holds a Master of Science degree in Quantitative Biology from the University of Texas – Arlington and has held multiple clinical leadership roles, most recently as a Director of Global Clinical Operations for New World Medical.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
