The people:

David Hammond is the principal consultant at Hammond Clinical Trial Consulting, LLC where his practice focuses on regulatory issues associated with research, development and FDA requirements that apply to bio-medical and health products. Mr. Hammond holds an MS in Biomedical Regulatory Affairs and has an extensive background in medical research. He provides advice to early stage and established biomedical product companies on regulatory issues across the product lifecycle, from bench top to clinical research, FDA pre-market requirements, labeling, and promotion and advertising. A key aspect of his practice focuses on working with companies creating Lab Developed Tests (LDTs) and helping those groups maneuver the changing FDA regulations.

David also holds a faculty position in the University of Washington School of Pharmacy's Biomedical Regulatory Affairs program and is Director of the Clinical Research program.

Mr. Hammond advises clients on a diverse group of medical and health products, including medical devices, drugs, biologics, and dietary supplements. He has experience with in vitro diagnostics, medical software, blood & plasma products, usability evaluations, and health and wellness devices. He advises clients engaged in all aspects of clinical research, including industry sponsors, non-profit research organizations, Institutional Review Boards (IRBs), and CROs. Mr. Hammond advises clients on compliance with FDA, DHHS and HIPAA regulations governing use of human subjects; he has extensive hands-on experience with human subjects protection and IRB functions as the Research Integrity Director and Chair of the Bastyr University IRB.

David has presented at several national and regional conferences on clinical research and regulatory topics and is the author of numerous articles in ACRP’s Clinical Research, RAPS’ Focus and the Journal of Clinical Research Best Practice.

Sarah Hammond is the primary consultant for software, clinical data management and electronic medical records systems.  Sarahhas 16 years of experience in the implementation of electronic systems for medical records, clinical data and budget management.  Sarah has worked in industry and academic environments.  She has been a guest lecturer in the Masters in Biomedical Regulatory Affairs and the Health Informatics and Health Information Management program.  She has co-authored articles on validating clinical data management software.

Over the last six years, she has worked as an independent consultant assisting companies in validating custom and commercial clinical data management software, designing and reviewing software test plans for medical device software and software as a medical device, and ensuring compliance with multiple regulatory environments.