Faegre Drinker Biddle & Reath LLP, a Delaware limited liability partnership | This website contains attorney advertising.

Overview

Whether as an academic medical center, research institute, cutting-edge physician practice, pharmaceutical company, device manufacturer or clinical research organization, your focus is on medical breakthroughs and new treatment options that enhance patient care. We partner with you as you seek to ensure that your clinical research programs adhere to all accepted clinical trial guidelines, including clinical trial design and agreements, Food and Drug Administration approvals and commercialization. We help you navigate institutional review board requirements and human-subject protection rules at both the federal and state levels. We can serve as an extension of your team to help you write grants, draft budgets, develop contracts and manage data rights. We can help manage your clinical research compliance needs so that you can focus on scientific pursuits. Our attorneys, consultants and other professionals work with clinical research organizations across the industry in the U.S. and internationally.

Insights & Events

Latest

Updates August 2025

Effects of the One Big Beautiful Bill Act on Health Care and Pharma; and More

Biopharma & Medical Devices Briefing
7 min read  
Updates June 2025

Texas Genomic Act: A New Era of Genetic Privacy Legislation

Including Prohibitions on Genetic Sequencing, Storage and Sale of Genomic Information
7 min read  
Press Release May 2025

Faegre Drinker Grows Life Sciences Consulting Team With Nationally Recognized Patient Experience Researcher Holly Peay, PhD

2 min read  
Updates May 2025

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

Reminder of Importance of Adequately Vetting Contract Research Organizations
5 min read  
Media Mentions February 2025

Doriann Cain Provides Insight in Navigating HIPAA Compliance With Becker’s Hospital Review

1 min read  
Updates January 2025

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

A Seven-Step Process and Detailed Recommendations for Submissions
6 min read  
Updates September 2024

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

3 min read  
Media Mentions January 2023

Steve Lokensgard Addresses Health Care Compliance Programs With Compliance Today

1 min read  
Published Articles February 2022

The Economic Burden of Rare Diseases: Quantifying the Sizeable Collective Burden and Offering Solutions

1 min read  
Updates November 2020

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

7 min read  

Related Industries