Service Page: Study Conduct
The procedures and pathways defined by the Medical Monitor in the Medical Management Plan, the Protocol Deviations Guidance document, and Safety Management Plan are executed as planned during the study conduct to drive the study progression in the right direction with the aim of meeting study-specific milestones and projections in the process.
One of the primary responsibilities of a medical monitor is to support the study team and sites by providing daily medical guidance under any circumstance and, in the process, to build a knowledge base for the medical and scientific needs of the study, which can be accessed by the whole study team.
Key Medical Activities:
- Medical and Scientific support to investigational sites and various members of the cross-functional operations team
- Eligibility Review
- Management of Medical Questions and Guidance Requests
- Regular Review of Study Data, both aggregate data and individual patient’s data
- Management of Protocol Deviations
- Communication and Escalation