Taking Risk out of REMS

Organizations – such as, but not limited to, drug prescription management and healthcare research companies – that are being asked by their clients to develop a Risk Evaluation and Mitigation Strategy (REMS) using existing computerized systems to process/maintain/report relevant information (e.g., prescriptions, signals) have asked The Practical Solutions Group, LLC to help ensure that the 21 CFR part 11 regulation and the Privacy and Security rules of HIPAA are being adhered to in the resulting REMS. Given the FDA focus on and interest in REMS, companies have no choice but to build the necessary compliance measures into their REMS-related functionality, and the practical ones want to “do it right the first time.”

So how have we helped? Based on the specific need, we have provided turnkey solutions, at both the strategic and tactical levels, including some or all of the following:

• Clarifying the company’s 21 CFR part 11 and HIPAA responsibilities with respect to REMS vs. its client’s responsibilities and suggesting applicable contract-related wording in order to minimize any risks for the company (our client).
• Identifying organizational activities and dependencies required to 1) achieve and maintain regulatory compliance in a timeframe required by our client’s client and 2) improve operational efficiencies as a side benefit.
• Providing recommendations regarding restructuring/modifying existing computerized system(s) and/or infrastructure to meet REMS regulatory compliance standards with minimum effort and cost.
• Developing and delivering customized regulatory training regarding the impact and implementation of 21 CFR part 11 and HIPAA requirements on the given REMS.
• Recommending REMS specialists to address non-computer-system-related REMS issues.

Our approach has helped our clients to focus on providing REMS deliverables to its clients without having to spend the time on researching the operational and regulatory risks associated with such projects.