FDA Legal Services Relating to Clinical Research

FDACounsel.com -- Legal Services -- for the life of a Life Sciences company

CLINICAL RESEARCH SERVICES

Clinical Trial and Other Sourcing Agreements
  ♦ CROs
     • Sponsor Master Services Agreements
     • Clinical trials management
  ♦ Investigators
  ♦ Contract Labs
     • Preclinical testing
  ♦ IRBs
  ♦ Active Pharmaceutical Ingredient (API) supply sourcing
  ♦ Component sourcing deals
  ♦ Medical advisory boards
     • structure
     • function
  ♦ Consultants
Commercial Agreements – Clinical Research Issues Presented By:
  ♦ Acquisitions involving pipeline products
  ♦ Clinical data ownership

Good Clinical Practice (“GCP”) -- Compliance & Training
  ♦ SOPs –
       • drafting
       • review
  ♦ Compliance
       • audits
       • training
  ♦ HIPAA and privacy considerations
       • implementing procedures in clinical trials
       • consents
  ♦ State regulatory requirements
Clinical Trial Protocol Reviews
Informed Consent Reviews
Financial Disclosure Requirements – Compliance and Strategies
  ♦ Federal: FDA & HHS
  ♦ Institutional (e.g., university, hospital)
  ♦ Clinical trial design to minimize conflicts
State Law Issues
  ♦ Privacy
  ♦ Medical Records

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For presentations and articles on Clinical Research, just click here ...