Amarex Clinical Research

Managing Clinical Trials with Speed and Precision

ICH Guidance and
FDA Regulatory Updates

ICH/FDA Guideline CDs - to obtain your free CDs, copy and paste the titles of interest, listed immediately below, into the email created with the following link,
ICH-guidelines@amarexcro.com

  • Anti-microbials
  • Cancer Endpoints
  • Clinical Trial Design
  • Electronic Submissions
  • European Union Clinical Trials
  • Infectious Diseases
  • IRB and DSMB
  • Medical Devices
  • Monoclonals
  • Part 11 Compliance
  • Pre-Clinical Testing
  • Safety Reporting
  • Special Procedures and Meetings
  • Vaccine Development

White Papers / Abstracts /Summaries of FDA issues relevant to clinical trial design and conduct:

Please check back at a later date.