Clinical Trials & Medical Research Legal Services

Comprehensive Clinical Research Legal Support

We provide specialized legal counsel to all stakeholders in the clinical research process:

• Pharmaceutical and biotech research sponsors

• Academic medical centers and research institutions

• Principal investigators and research teams

• Clinical Research Organizations (CROs)

• Site Management Organizations (SMOs)

• Institutional Review Boards (IRBs

Research Compliance & Risk Management

We help organizations navigate the complex regulatory framework governing clinical research:

• FDA compliance and submissions

• HIPAA and patient privacy protection

• Informed consent documentation

• IRB submission requirements

• Financial conflict of interest policies

• Research misconduct procedures

• International research regulations

• Grant and funding compliance

Clinical Trial Agreement Expertise

Our deep understanding of clinical trial regulations ensures your research agreements are both compliant and protective. We draft, review, and negotiate:

• Clinical Trial Agreements (CTAs)

• Master Service Agreements (MSAs)

• Site agreements

• Confidentiality agreements

• Material Transfer Agreements (MTAs)

• Data Use Agreements (DUAs)

Strategic Research Partnership Support

Beyond regulatory compliance, we provide strategic guidance to:

• Structure research collaborations

• Protect intellectual property

• Manage liability exposure

• Develop institutional policies

• Address patient safety requirements

• Navigate federal grant requirements

• Ensure research integrity