REMS: To Outsource or Not to Outsource?
Risk Evaluation and Mitigation Strategy (REMS) is a complex and evolving area. While the U.S. Food and Drug Administration (FDA) ultimately determines if a REMS program is necessary, it’s important to understand and monitor regulatory, legislative, and market trends and issues involving product safety and benefit-risk balance. Once it is determined that a REMS is needed, the challenging process of planning and implementing the REMS begins. In this blog, Debbie Cheslow, director, risk management programs for Evidera, a PPD business, discusses the pros and cons of outsourcing a REMS program versus developing one internally.
REMS PROGRAM: A CROSS-FUNCTIONAL CHALLENGE
Implementing and managing a REMS program requires specific skills and expertise. Given the various components of a REMS program, the first thing to consider is resources. A REMS program may require experts in many functional areas, from epidemiology, risk management and regulatory affairs to finance, information technology, and medical writing, just to name a few. In addition, strong project management is critical for a successful REMS program.
It’s important to determine whether your organization can manage those resources internally, especially if you’re building a brand-new REMS program. Not all organizations have staff with these niche skillsets or the ability to take on new staff. You will need to assess the capabilities and availabilities of resources from several functional areas and determine whether they have specific experience with REMS, not just their respective areas of expertise. Also, staff might not be needed full time if you only have one or two REMS programs. Outsourcing these functions would give you the expertise you need when you need it in a cost-effective manner.
Alignment of REMS resources is also critical. Internal departments may have different decision-making processes. It’s important to establish and align the various goals across the organization. A vendor can help streamline that process by creating and managing one governance committee that can help to bring your organization into alignment. Additionally, if you are a member of a single shared REMS (a consortium of multiple companies), a Project Management Office (PMO) vendor can objectively manage complex logistics and meetings, guide consensus planning, and handle voting and decisions.
ROLE OF TECHNOLOGY FOR A REMS PROGRAM
Infrastructure (i.e., website, call center, database, fulfillment) is another key component of REMS. If your organization does not have the existing infrastructure, it will have to build, maintain, and update one, as well as keep up to date on the latest guidance and ensure compliance. This can be a huge investment. There are a lot of metrics from websites, call centers, printing, and fulfillment that need to be reported for assessments. Vendors can pull those metrics and statistics quickly and efficiently.
It’s important to gauge your organization’s IT structure, bandwidth, and technology capabilities in addition to how a call center would escalate issues and evaluate risk. This is an area where a blended approach might work, but cost efficiency should be weighed along with an honest evaluation of capabilities that will produce the best, most effective results. It takes years to build and manage a REMS, especially a complex REMS. Is it worth spending the money needed to develop resources versus outsourcing?
AN EVOLVING SAFETY LANDSCAPE
Whether you keep your REMS in-house or contract with an outside vendor, it’s important to plan early in the process and get a system in place that can be approved by regulators. A robust risk management strategy that ensures the benefits of your product outweigh the risks to the patient is critical to successful and sustained patient access to safe and effective treatments.