Pre-Market and Post-Approval

Clinical registries for medical technology evaluation

Clinical registries are powerful tools, repositories of vast amounts of clinical data that are centrally located for ready access and analysis. And because registries track patient outcomes over time, they offer manufacturers a clearer picture of the clinical efficacy of their technologies.

In collaboration with medical societies, M2S uses the clinical registry data on our M2S PATHWAYS platform to provide a more effective, real world basis for both pre-market and post-approval surveillance compared to traditional projects.

 

TRACKING AND ANALYSIS

Pre-Market: Existing clinical registry data can be used by R&D and Marketing for retrospective data analysis to improve products and market research to define patient selection in current practice.

Post Approval: Our client registries offer a cost-effective basis for prospective observational studies of device performance, randomized controlled trials (RCT) of new devices, post approval studies of recently approved devices and investigational device exemption (IDE) studies of new devices.

M2S offers tracking and analysis for 13 clinical registries, over 350 facilities and 230,000+ procedures for hospitals and physicians. Together, this resource, combined our years of data gathering and analysis skills, help you guide your product from idea to introduction to post-approval.

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