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:
- Perform review of data generated by statistical analyses
- Request additional tables or analyses where appropriate
- Reviews individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities
- Perform all reviews and procedures required for database lock
- Reviews all patients narratives
TRIP REPORT ISSUES TRENDING:
- Review outstanding medical or GCP issues report and address issues across the study
- PROVIDE STUDY TEAM WITH MEDICAL EXPERTISE DURING KEY ACTIVITIES
- Issue resolution
- Audit response
- Study closeout / inspection readiness
- PARTICIPATE IN PROTOCOL AND SAFETY TRAINING
- Deliver protocol and safety training during Investigator meeting at the study level
- Create medical training materials for Site Management
- Train clinical staff on the protocol
- Available to answer questions specific to the protocol during (or soon after) the training from the Site Manager
- Answer medical/safety questions and resolve medical/safety issues from sites through Site Manager/Regional Study Manager/Regional Medical Monitor (RMM) if RMM is unable to answer specific questions, or as another point of contact if RMM is not available:
Questions from Sites on Protocol:
- Answer medical and inclusion/exclusion questions
- Ensure answers are consistent across all regions
- INTERACT WITH REGULATORY GROUPS AND INTERNAL AUDITING GROUPS ON A STUDY LEVEL
- Data Monitoring Committee Interaction
- Support notified bodies and Ministries of Health Interaction/ inspection process
- Accountable for providing a response to regulatory agency inspection observations and internal audits
- Support regulatory update and registration submissions
- CONTRIBUTE TO, REVIEW, AND EDIT CLINICAL STUDY REPORTS (CSR)
- Approve Patient Narratives
- Participate in Decision making process with the points of preparation for senior management
- Contact us for more information.