We partner with life sciences companies to help them navigate the challenges and opportunities of moving from research to clinical development, in the US and internationally. That includes working with clinical operations teams, regulatory personnel, and senior management to commence clinical research and address any obstacles that may arise.
Our cross-functional team offers expertise in FDA regulations, healthcare compliance, commercial contracting, privacy, cybersecurity, product liability, and insurance. We provide guidance on the development, execution, and management of clinical trials, including coordinating documentation and obtaining necessary authorizations to ensure compliance with complex laws and regulations.
We also advise on preparing and negotiating clinical trial agreements and informed consents, guiding regulatory compliance and communications during ongoing clinical research, ensuring privacy protection and understanding bioethics, and addressing liability and navigating insurance.
Representative Experience & Featured Insights
- Advise on interactions with the FDA, sites, CROs, and IRBs during clinical research planning and execution
- Provide guidance on appropriate interactions with patients and patient advocacy organizations, including the review of clinical trial recruitment materials
- Advise clients on evaluating and addressing significant data integrity and GCP compliance concerns raised during or after completion of their clinical trials
- Counsel clients on managing emerging safety issues in clinical trials, including through the implementation of protocol amendments and mitigation strategies
- Coordinate responses to clinical holds and inspection findings for clinical trial service providers
- Prepare and negotiate domestic and international clinical trial agreements and other industry-sponsored research agreements and related consent and assent documentation
- Advise on arrangements with key opinion leaders and scientific advisory boards, including consideration of financial interest disclosure requirements for investigators
- Advise on compliance with subject privacy requirements and cross-border transmission of protected information
- Provide counsel on the Medicare Secondary Payer rule and its effects on subject injury liabilities in connection with clinical research
- Advise on clinical trial insurance needs and product liability considerations for investigational articles
- Coordinate with Goodwin's cross-functional Clinical Services team to prepare and review disclosure of safety information and data releases for ongoing and recently completed clinical trials in medical congresses, public company securities filings, and press releases
- A Look Ahead in Life Sciences: What We Are Tracking in Q1 2023 and Beyond
- Leveraging Investigator-Initiated Trials in Rare Disease Drug Development (February 23, 2023)
- Understanding Data Monitoring Committee Conflict of Interest Limitations ( February 9, 2023)
- Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now (June 28, 2022)
- Clinical Trial Diversity Planning for Sponsors: What to Know About FDA’s Recent Draft Guidance (April 29, 2022)
- For Clinical Trial Recruiting, Words Matter (February 1, 2022)
- Medicare Agrees to Limited Payment for New Alzheimer’s Drug (January 14, 2022)
- On Remote Control: FDA Issues Draft Guidance to Facilitate Use of Digital Health Technologies for Remote Data Acquisition in Clinical Trials (January 4, 2022)
- Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products (December 17, 2021)
- Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation (November 22, 2021)
- Common GCP Bioresearch Monitoring Violations (July 21, 2021)
- FDA Answers New Questions on Foreign Trial Sites Operating Under INDs (May 25, 2021)
- Real-World Evidence: Challenges and Opportunities During COVID-19 (July 29, 2020)
- What are Clinical Outcome Assessments (COAs) and Can They be Used to Support Approval and/or Labeling Claims? (July 23, 2020)
- Modifying Clinical Trials: Regulatory, Liability & Insurance Considerations (April 10, 2020)
- Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA (March 18, 2020)
- Clinical Holds: Tips for Handling FDA's Call and What to Do Next (February 27, 2020)
- Q&A on FDA’s Requirements Related to Financial Disclosure by Clinical Investigators (February 6, 2020)
Contacts
- /en/people/t/tibbets-julie
Julie Tibbets
PartnerChair, Life Sciences Regulatory & Compliance Practice - /en/people/c/cohen-roger
Roger A. Cohen
Partner - /en/people/s/scott-gretchen
Gretchen Scott
Partner - /en/people/o/oetheimer-richard
Richard A. Oetheimer
Of Counsel - /en/people/m/mukherjee-brian
Brian H. Mukherjee
Counsel - /en/people/w/wetzel-matt
Matt Wetzel
PartnerLife Sciences Regulatory & Compliance - /en/people/w/wang-zhenghui
Zhenghui (Alan) Wang Ph.D.
Partner