11835 W Olympic Blvd, 9th Floor Los Angeles, CA 90064

Clinical Research

Fenton Nelson regularly advises clients on ensuring regulatory compliance in clinical research trials.  We have assisted client in all phases of the regulatory process, including:

  • Identifying legal issues in structuring clinical trials, including Stark and Anti-Kickback issues in relationships with participating physician investigators and consultants;

  • Ensuring compliance with Food & Drug Administration (FDA) requirements, including investigational device exemption (IDE) applications and off-label use issues;

  • Ensuring compliance with Office of Human Research Protection (OHRP), National Institutes of Health (NIH) and Office of Research Integrity (ORI) regulatory requirements;

  • Ensuring compliance with FDA and state informed consent and electronic records requirements;

  • Obtaining Institutional Review Board (IRB) approval;

  • Drafting agreements, consents, and other documentation necessary for clinical research trials;

  • Responding to federal and state investigations of clinical research trials and, when necessary, defending civil administrative proceedings.


A representative sample of our experience in the area of clinical research includes:

  • Preparing advisory opinions on compliance issues in clinical research investigations;


  • Successfully negotiating the closure without action of an investigation of a clinical research trial;

  • Assisting an organizer of clinical trials initiating trials in California in developing a compliance plan addressing California state law;

  • Developing, on behalf of a medical device maker, medical a corrective action plan to address Anti-Kickback Statute compliance issues, including compliance training for our client’s marketers.