PharPoint’s skilled in-house MD and network of specialist physicians provide Sponsors with medical monitoring services.
Our study physicians work collaboratively as integrated members of your team, supporting project teams, sites, and Sponsors with information to facilitate discussion and decision-making for the medical aspects of a study.
Services include:
- 24/7 Medical oversight and review of safety data (AEs, SAEs, SUSARs), labs and patient eligibility
- Ensure the safety of patients during study conduct
- Runs the Independent Data Monitoring Committee (IDMC)/Safety Review Committee (SRC)
- Responsible for medical clarifications on protocol specifics or study conduct (e.g., inclusion/exclusion criteria, concomitant medications, or adverse event management or reporting)
- Protocol deviation and AE/SAE adjudication meetings
- Write/review medical portion of protocol
- Assist in developing study-related plans (medical monitoring plan, safety monitoring plan, and protocol deviation handling plan)