Introduction

As the number of regulations keep increasing and becoming more and more datadriven, the concept of Regulatory Information Management (RIM) keeps evolving and becoming more comprehensive, but also more complex. Driven by these changes, the pharmaceutical and MedTech industries are looking to transform the way they manage regulatory information from a siloed, legacy-driven approach to a comprehensive, end-to-end approach where business processes, information and data seamlessly flow across functional and organizational boundaries.

As the regulatory landscape and client requirements change, so do the offerings of regulatory technology vendors, with the majority now either working on or offering end-to-end (E2E) RIM platforms to support this evolution. The E2E model is built on the same assumptions that have successfully driven Enterprise Resource Planning (ERP) system adoption over the last 25 years, namely that a pre-integrated, modular platform will deliver significantly lower risk, increase cost-efficiency, and provide a consistently better user 
experience. However, it is still early days for E2E RIM, with low maturity within the industry.

End-to-end systems can offer a more seamless regulatory management experience; however, some customers will find the customization and adoption journey to be more complex than initially anticipated, especially if there are unique process requirements. This may be frustrating for users who are accustomed to well-established workflows and can make user adoption a tougher sell.

To mitigate these issues and accelerate acceptance of any new RIM solution, we encourage companies to take a “blueprint approach” to their platform roll out.

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