Thomas D. Shrack
500 N. Meridian Street
Indianapolis, IN 46204-1293
Phone: (317) 977-1496
Fax: (317) 633-4878
Mr. Shrack focuses his practice on clinical services and patient care issues, corporate counsel services, medical staff relations, regulatory and compliance and legal and ethical issues involved in clinical research activities. He has participated in clinical research as ultrasonographer prior to practicing law, is currently a voting member on two hospital institutional review boards and has significant experience in negotiating clinical research study and material transfer agreements.
Mr. Shrack has also provided counsel on issues including, but not limited to, the development, registration and conduct of clinical investigations, government (FDA, OIG, DHHS) audits and investigations, the impact of fraud and abuse laws and False Claims Act on research, FDA regulations, the Common Rule, pharmaceutical pricing and clinical trial billing compliance, medical device approval submissions (PMA, 510k) and various reporting obligations. He has advised clients on compliance with federal, state and international laws and regulations regarding the collection, transfer and sharing of data, compliance with applicable laws regarding regulatory review and approvals in the research process and the identification and allocation of intellectual property rights resulting from research data and activities. Mr. Shrack has made presentations and written several articles on these and other topics.
- Miami University, Ohio B.A. – 1987
- Indiana University Robert H. McKinney School of Law, J.D., cum laude – 2003
- American Health Lawyers Association
- Health Care Compliance Association
- Indiana State Bar Association
- Indianapolis Bar Association
- Registered Vascular Technologist, CorVasc MDs, P.C., 1990-2003
- Hall Render’s Practical Health – July/August 2010 [07/01/2010]