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.