CLINICAL RESEARCH, FINANCIAL DISCLOSURE & THE SUNSHINE ACT
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 AgreementsClinical Research Issues
Presented By:
    ♦ Acquisitions involving pipeline products
    ♦ Clinical data ownership

State Law Issues
    Privacy
    ♦ Medical Records
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 & Sunshine Act
Requirements – Compliance and Strategies
    Financial Disclosure Issues
    ♦ Federal:  FDA & HHS
    ♦ Institutional (e.g., university, hospital)
    ♦ Clinical trial design to minimize conflicts
     Sunshine Act Compliance
    ♦ Requirements
    ♦ Exemptions
    ♦ Impact on Research Payments
FDA Legal Services --  for the life of a Life Sciences company
Product/Issue Specific
FDA Legal Services
Ad Hoc
FDA Legal Services
Links to My Other Services
Life Cycle
FDA Legal Services
© 2014  Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
For presentations and articles on Clinical Research, just click here ...
Michael A. Swit
For presentations and articles on Financial Disclosure & The Sunshine Act, just click here ...