Clinical Research / Life Sciences
Breazeale attorneys offer extensive experience in advising clients on a wide range of clinical research matters, including compliance with complex legal and regulatory frameworks, and managing relationships between health care facilities, research institutions, institutional review boards (IRBs), principal investigators, academic institutions, and industry sponsors. Our team understands the significant ethical, practical, and regulatory challenges involved in clinical research, and we work closely with clients to ensure their projects advance in a compliant and efficient manner.
Breazeale provides comprehensive counsel on human subject protection, assisting with the negotiation and execution of research agreements, such as clinical trial agreements and material transfer agreements. We ensure clients comply with federal and state laws regarding the collection, transfer, and sharing of data, and navigate the regulatory review and approval processes critical to clinical research.
Our attorneys' practical experience is strengthened by a deep understanding of scientific, regulatory, and IRB procedures. BSW’s team includes Board-Certified Health Law Specialists with decades of experience in research. We also assist in the development, evaluation, and improvement of research programs, providing tailored compliance solutions and day-to-day support for research operations when needed.
