Clinical Research & Development

From Phase I to marketing authorisation application

Clinical Development

  • Medical and scientific strategy for:
    • Drug development plans
    • Design and conduct of clinical trials
  • Write and review
    • Protocols
    • Informed consents
    • Safety narratives
    • Clinical trial reports
    • Investigator brochures
    • Annual reports and study updates
  • Organise or represent customer at:
    • Steering committee meetings
    • Data and safety monitoring boards
    • Investigator meetings
  • Clinical trial management and conduct
    • Provide cover as Medical Monitor
    • Investigators and Sites Identification
    • Investigators Training and Support
    • Study recruitment optimisation
    • Review of adverse events and safety monitoring
  • Medical data review and review of coding

Regulatory Affairs

  • Summaries of Efficacy and Safety, Clinical Overviews
  • Health Authority Briefing packages
  • Orphan Drug Applications
  • PIPs
  • Clinical Trial Applications
  • Core Data Sheets, Target Labelling and Patient Information Leaflets