Addressing the clinical implications of research

Rho’s Medical Monitors come from life science careers, including experience in medical and academic institutions. Our experts have both clinical and research experience, and some serve as academic investigators. They are able to apply their practical knowledge and experience to present solutions for the issues that occur in clinical trials and research studies.

We have the capacity to assist small niche studies at single sites or large-scale clinical trials involving large patient populations. Our medical monitors understand the role clinical investigation plays in the effective introduction and acceptance of new therapies. They also have insight into the potential implications for future development of an area of research.

Key reviews ensure quality

Our Medical Monitors serve as strong inside consultants to the internal Rho study team. To enhance the quality of study deliverables, we can offer medical review of key documents including protocols, case report forms, clinical study reports, data analyses, and regulatory submissions. Our medical staff brings practical clinical perspective to assist study teams and clients with every aspect of subject safety in clinical trials. This includes event reporting and analysis, interpretation of safety and outcome data, and evaluation of the clinical implications of study results.

Our Medical Monitoring services

• Medical consultation: reviewing and evaluating event collection and reporting, data analysis, clinical study reports (CSRs), and regulatory submissions
• Product safety: processing serious adverse event reports including evaluation of relatedness and analysis of similar events for expedited cases; identifying and evaluating safety signals, trends, and events
• Site education: training study teams on disease states, treatments, protocol compliance, inclusion and exclusion criteria, procedures, and assessments