We believe successful drug development requires:

  • Thorough early strategic planning
  • Intensive oversight of implementation procedures

We act as your development team.

We are not a CRO, but select the best CROs for your project and supervise CROs to help execute your programs.

Project Management

KM can manage entire development including manufacturing, non-clinical program, clinical development, regulatory strategy and patent strategy.

Clinical Study Management

  • Based on input from regulatory and clinical experts, KM proposes a development plan
  • KM implements the development plan and can manage the clinical development
  • We use and supervise CROs to help execute our programs, for example to monitor clinical trials
  • For each study KM can
    • Draft protocol, CRF, study materials
    • Select Sites/CROs
    • Organize Steering Committee
    • Organize Data Safety Monitoring Board (DSMB)
    • Train CROs and sites
    • Generate and manage budget and timeline
    • Manage
      • Monitoring
      • Data management
      • Drug supply
      • Ongoing efficacy/safety data review
    • Propose statistical analyses plan
    • Generate the final study report