EFFECTIVE RESULTS

Health Care Services

Clinical Research

Pepper is experienced in advising health care and life sciences clients in a wide variety of clinical research matters, including clinical research agreements and related commercial matters, and compliance with Food and Drug Administration regulations, as well as relations with federal grant-making agencies.

We help design and implement organizational models, business processes and technology solutions, and help institutions successfully navigate the billing rules and regulations related to Medicare coverage of clinical research.

We routinely handle collaboration, licensing, product acquisition/divestiture, outsourcing, manufacturing, supply, distribution, clinical trial, clinical research and other agreements. We are experienced in advising clients about the sophisticated issues that often arise in this area, including intellectual property contribution, development and prosecution; access to data generated in investigator-sponsored trials; publication procedures; indemnity; and sponsored research and other forms of economic assistance.