Peachtree Medical Monitors serve a pivotal role in the organization and on project teams. The medical monitor’s primary responsibilities are to provide medical oversight of clinical trial projects – ensuring protocol adherence and subject safety.
Our medical monitors possess significant experience across multiple therapeutic areas – providing keen insights during protocol development by identifying operational issues/trends during conduct.
Key to the success of Peachtree medical monitoring support is the Medical Monitoring Plan – developed upon award in conjunction with Sponsor review and approval. The plan describes the team structure, shared responsibilities, workflow, communication plan, documentation, and all additional requirements for medical monitoring specific to the trial. RESULT: Seamless medical stewardship of the study.
Primary responsibilities incorporated in the plan include, but are not limited to:
Medical support of the project team on the components which are critical to successful study conduct – therapeutic area and study conduct training
Medical support for clinical sites to address issues such as subject entry criteria, protocol deviations, safety concerns – ensure distribution of critical medical issues/decisions to all study stakeholders
Facilitate regular medical oversight meetings with Sponsor medical counterparts
Routine review of critical safety data such as adverse events, SAEs, concomitant medications, critical laboratory values, and medical histories
Proactively address site issues and inquiries – medical decision making must be quickly and completely transmitted to the CRAs in the field to minimize variability between sites and assure consistency of medical approach, both of which are essential for eliminating or reducing the ‘noise’ of multi-center trials.