MMS - Comprehensive Safety & Risk Management Software

Our Pharmacovigilance (PV) team will serve as an extension of your PV department. Starting in early development, MMS will build compliant expedited reporting processes, monitor for safety signals, and prepare all documents to meet regulatory reporting requirements. MMS understands that as your development program progresses additional data sources such as Real World Data (RWD), Real World Evidence (RWE), and patient perspectives may be used to characterize differentiators for your product. Accordingly, MMS will customize the strategy to suit the needs of your program as it achieves key milestones. Then, we will work with you to review the data and to understand the emerging benefit-risk profile through a structured benefit-risk assessment which will help your organization make informed investment decisions.   
 
Continuing into peri- and post-approval activities, our team of experts can help you define and manage your post-market risk management strategy.  Our teams are experts in planning, developing, and managing a variety of Risk Evaluation and Mitigation Strategies (REMS) including program management and coordination of shared system REMS across a set of companies.
 
The figure below details where, when, and how MMS comprehensive safety experts provide support.

Risk Evaluation and Mitigation Strategy (REMS)

Choosing the right partner for your REMS support is crucial to ensure compliance with FDA requirements and to effectively manage the safety profile of your drug. This allows you to focus on bringing your drug to market safely and efficiently. Let MMS help you navigate the complexities of REMS and achieve regulatory success.

MMS is the right clinical research organization (CRO) for your REMS support or to act as a program manager for shared REMS for the following reasons: