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We apply our depth of knowledge and experience to ensure your study is safe and accurate.

At the heart of our work is the mission to transform human health, while safeguarding the welfare of patients. With more than 30 years of academic, clinical and industry experience, our medical monitors have deep therapeutic knowledge and clinical experience. We provide both strategic and operational advice to sponsors, the sites and project teams throughout the duration of your study.

Medical Expertise and Oversight

Providing proactive insight, planning and safety accountability for the duration of the study.

  • Protocol review and consulting on patient selection criteria, endpoint determination, feasibility assessment and site selection
  • Medical Monitoring Plan adapted to the study:
    • Outlines responsibilities of the Medical Monitor and the communication flow with study stakeholders
    • Alimentiv standard process and template
  • Provide therapeutic/indication training to project team and site personnel
  • Presentation at investigator meetings

Medical Review

Ensuring protocol adherence to patient eligibility criteria and medical congruency between medical history, concomitant medication and adverse events.

  • Medical review of eligibility at study start:
    • At the request of the site – determination of screening/randomization eligibility
  • Medical review of protocol adherence post-randomization, as part of routine monitoring activities, including documentation of protocol deviations
  • Medical review of laboratory data:
    • Out-of-range values
  • Periodic medical data review
    • AE listings
    • Concomitant medications listings
    • Coding
  • Medical input/review of tables, listings, figures
  • Regular Medical review with sponsor representative

Medical Communication

Providing medical support for investigative sites throughout the duration of the study.

  • Consultation with the site investigators on medical questions or issues:
    • Subject eligibility and/or ongoing management
    • Use of concomitant medications
    • Protocol and study algorithms or procedures
    • Study drug/investigational product/device
  • Medical monitor availability:
    • 24/7 for urgent questions that may affect patients’ safety and wellbeing
    • Within 24 business hours from receipt of urgent but not safety-related questions
    • Within 48 hours for non-urgent questions

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