Healthcare Research & Academic Institutions

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Academic medical centers, universities, hospitals, and clinical research organizations face unique legal challenges at the intersection of healthcare and research. Navigating complex privacy laws, FDA regulations, human subjects protections, and compliance with federal agencies requires focused legal guidance.

Dickinson Wright’s Healthcare Research & Academic Institutions team advises clients across all stages of research and clinical trials — from contract negotiation and compliance programs to government audits and regulatory investigations.

Who We Serve

  • Academic medical centers

  • Universities

  • Hospitals

  • Physician groups

  • Clinical research organizations (CROs)

  • Independent research sites

Our Services

  • Structuring and negotiating clinical trial and research affiliation agreements

  • Human and animal research compliance (FDA, NIH, CDC)

  • HIPAA, HITECH, and global privacy compliance (GDPR and other laws)

  • Guidance on FDA regulatory requirements for research and investigational products

  • Advising on transparency and fraud/abuse laws

  • Representation in audits and investigations by FDA, OHRP, OCR, and ORI

  • Sensitive data compliance (genetic, substance use, mental health data)

Our team helps clients reduce legal risk, maintain compliance, and advance cutting-edge healthcare and scientific research.

Representative Matters

–Developed compliance programs for pharmaceutical manufactures and academic centers.

–Represented pharmaceutical manufacturers, academic medical centers and pharmaceutical service companies in connection with federal and state False Claims Act Counseled a private medical research institute on development and approval of multiple medical technologies, including biomaterials, personalized medicine and anti-aging technologies.

–Counseled a private foundation serving as a partnership intermediary with Federal laboratories, including master-level cooperative research and development agreements (CRADA’s).

–Created a clinical research contract and provided regulatory counsel to cardiac device company engaged in national, multi-site clinical research trial as well as a publicly-traded medical technology company conducting multi-site clinical research trial.

 

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