Stark and Anti-kickback Issues
Clinical Trial Agreement Drafting and Review
The FDA and OHRP enforcement efforts are increasing in the area of Clinical Research. Research and related rules are complex. Physician-investigators are busy and focused on care for their patients. Administrative support if often lacking in community hospitals and medical practices.
These factors are a recipe for disaster as consequences for non-compliance can be severe and even criminal. The Cowell Law Corporation is here as a resource for hospitals and medical groups to assist in all facets of Clinical Research legal matters.