Risk Evaluation and Mitigation Strategies (REMS) B2B Services by CMK SELECT CMK SELECT CMK SELECT
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The Challenge A pharmaceutical technology company originally created a tool to validate the safety of medications, and while the tool effectively met the initial goal, after two years of use, many end-users wanted more automation, less paperwork and greater efficiencies. The process intended to help manufacturers determine whether their business processes met the standards defined
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Risk Evaluation and Mitigation Strategies (REMS) B2B Services

by CMK SELECT / /
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The Challenge

A pharmaceutical technology company originally created a tool to validate the safety of medications, and while the tool effectively met the initial goal, after two years of use, many end-users wanted more automation, less paperwork and greater efficiencies. The process intended to help manufacturers determine whether their business processes met the standards defined by the FDA’s Risk Evaluation and Mitigations Strategies (REMS)—a drug safety program that helps ensure that the benefits of certain medications outweigh their risks.

The Solution

The pharma tech company approached CMK Select to help streamline the REMS process for their drug manufacturing customer base. CMK worked with the client’s internal teams to implement an automated REMS tool that could be customized to each end-user while offering a standardized, paperless process across the entire user-base. The tool was also integrated into a common software program used by the drug manufacturers to significantly cut down on the steps required to complete the process.

Additionally, CMK worked with the client’s technology and business teams to help familiarize them with the in-house resources available to them and clarify each department’s role in implementing the new tool so that they could effectively maintain the new validation process and onboard new clients.

Results

Not only did CMK Select create a more efficient process for the end-user, but the team also created a better internal process for the client to onboard those users. What’s more, following the launch of the new tool, the client onboarded three new major clients—with three more expected by 2020. By delivering greater efficiencies, the new process has resulted in an increase in order volume to approximately 1,200 per day.

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