Clinical Trial/Research

Garfunkel Wild’s Clinical Trial/Research Practice Group is comprised of attorneys with extensive experience in advising clients on clinical research-related matters.  We provide advice on the legal and regulatory requirements and concerns raised by and related to participation in research and research-related activities, including compliance issues, reporting obligations, misconduct issues, and conflict of interest concerns.  We have worked extensively with health care facilities, research institutions, institutional review boards (IRBs), principal investigators, academic institutions, and sponsors/grantors regarding structuring research-related relationships and facilitating the ongoing operation of such research relationships by addressing their continuing legal concerns and issues.  Our attorneys are well versed in the requirements for drafting and negotiating research-related agreements, including clinical trial agreements, registry agreements, data sharing agreements, and material transfer agreements.  Our attorneys have extensive knowledge of the multitude of laws, rules, and regulations that affect any potential data-sharing relationship and provide advice on the regulatory requirements and limitations that need to be considered.
 
We have assisted entities with the initial creation and structuring of a research program (including IRB formation), including the creation of research-related policies and programs as well as research registries and databases.  Our client support may vary from providing day-to-day services to support the daily research activities to supporting in-house counsel in addressing research-related issues.  We have knowledge of and provide advice regarding issues of human subject protection; compliance with federal, state, and local 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 negotiation and execution of research agreements, including clinical trial, data sharing, material transfer, data use, and other related agreements.  We further provide counsel on intellectual property rights resulting from research data and activities as well as intellectual property transfer issues.  We advise and have participated in intellectual review board activities and related compliance concerns.
 
As always, our attorneys provide practical advice to allow our clients to navigate the complex legal requirements surrounding clinical and data research.
 
AREAS OF FOCUS:
 

• Research Contracting
• Human Subject Protection
• Institutional Review Boards
• Data Sharing