Clinical Trials Services

Accelerating the transition from discovery to development

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