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  • Stopping Pollution is the Best Solution

    "We won't have a society if
    we destroy the environment"

  • Be a Gapsos Supporter

    Lightening up the life

    Ipsum dolor sit amet consectetur adipisicing elit sed do eiusmod tempor incididunt labore dolore magna
    aliqua utas enim minim veniam tempore quis nostrud exercitation ullamco laboris
  • Be a Gapsos Supporter

    Lightening up the life

    Ipsum dolor sit amet consectetur adipisicing elit sed do eiusmod tempor incididunt labore dolore magna
    aliqua utas enim minim veniam tempore quis nostrud exercitation ullamco laboris
  • Be a Gapsos Supporter

    Lightening up the life

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    aliqua utas enim minim veniam tempore quis nostrud exercitation ullamco laboris

Global Medical Monitoring

Our medical monitors provide the following services at the global level as well as within the MOH’s jurisdiction of choice:

ACCOUNTABLE FOR SAFETY ACROSS THE STUDY

Manage SAEs working with the global teams in determining if a follow up action is needed. Participate in Safety Review Team, Data Monitoring Committee (DMC) and steering committees. Answer safety questions and review the literature as needed to address safety issues. Review ICFs from sites with deviations from approved SOP, GMP, etc. Safety communications to sites across the study. DESIGN PROTOCOL AND STRATEGY: Design clinical studies to meet the requirements outlined in the Target Product Profile. Direct a Clinical Scientists in writing the synopsis and protocol including all required elements. Approve protocol and amendments. Approve study template informed consent form. Provide global medical input into country feasibility. Coordinates with the Clinical Scientist to review and approve design deliverable.

STUDY LEVEL DATA REVIEW:

  1. Perform review of data generated by statistical analyses
  2. Request additional tables or analyses where appropriate
  3. Reviews individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities
  4. Perform all reviews and procedures required for database lock
  5. Reviews all patients narratives

TRIP REPORT ISSUES TRENDING:

-Specific medical/protocol training for RSMs and SMs -Site medical/protocol training for use during SIV

Questions from Sites on Protocol:

Contact us for more information.