Everything you always wanted to know about RIM (but were afraid to ask)

RIM Blog Series - Part 1: It’s not a technology, it’s a discipline

BY Sue Metz, Vice President Technical - 5.24.19

Fifteen years after coining the term Regulatory Information Management (RIM), I still see many conversations and discussions taking place about “What is RIM”.  To me, the definition has always been clear:   RIM is a discipline defined and created to support end to end Regulatory Processes in the Life Science industry.  As the regulations and processes change, so must the details - the discipline and definition of RIM remain the same.    

RIM is a discipline created to support Regulatory Processes
 

Over the past 15 years, regulatory agencies have evolved their requirements and needs.  Medicinal Products as well as Medical Devices have become more innovative and complex in design and function.  Technology plays a bigger role in drug delivery systems at every level – from the systems people use to design drug delivery to the novel ways companies exchange information with patients and stakeholders. New molecular entities (NME) require a shift in the conduct of Clinical Trials.  So, for RIM, a higher volume of increasingly complex data needs to be maintained and shared with regulatory authorities.  But – believe it or not, the basic regulatory processes haven’t actually changed dramatically.  I’ll go into the data aspects in an upcoming paper, but for now let’s stay focused on “RIM” as a discipline and the processes which support good Regulatory Information Management

The basic processes which support the Management of Regulatory Information are generally standard across the industry.  Certainly, there are process differences when talking about Medicinal Products vs. Medical Devices. Even within each type of product, there are some regional and cultural differences across the globe. Our experience over the past 15 years however have shown that the basic processes are generally the same.  The longevity and success of Parexel’s Liquent InSight RIM platform is proof of this as the software was designed and developed to support and follow Regulatory best practices.  Our regulatory best practice process flows, written by our regulatory experts, continue to be utilized by both existing and new clients alike.

At Parexel, not only has the development of our LIQUENT InSight RIM software followed Regulatory best practices, we have also defined a set of regulatory process flows that follow best practices in support of regulatory activities

Even though companies tend to have their own nuances, our experiences and successful implementations illustrate that after minor adjustments, our best practices ultimately become a company’s best practices.   Best practices lie at the heart of RIM, from a process, compliance  and a tool perspective.

Once it’s understood that RIM is a discipline, it becomes easier to understand some of the most important characteristics a RIM platform must have to support such an essential and complex set of processes. 

First and foremost, a RIM system must enable and support the best practices and not dictate a need for a new set of processes.  It’s important not to confuse this with ease of use.  Tools must be flexible and agile enough to make things easy on the user, being mindful of following the basics of well established and compliant regulatory processes.  The closer a set of tools can sit comfortably in the flow of every day work, the more the widespread benefits of RIM can permeate the business.  After all, the information contained in RIM systems is the lifeblood of an organization whether they know it or not. 

Maintaining solid RIM information is only the first step.  The true value comes in the many ways RIM information can be used to ease day to day operations and provide intelligent insights to enhance and support the business of life sciences.  The importance of a flexible, easy and intuitive way to query and visualize RIM information should not be underestimated.  A good analytics and reporting tool can improve efficiency in your organization, and ultimately increase productivity.  The many aspects of regulatory information needed across different departments should be easily and effectively shared.  A proven analytic tool can achieve this, breaking down silos that may exist due to the inability to share information.

The concept of RIM has been around for 15 years.  RIM is a discipline born out of the need to support Regulatory Processes in the Life Sciences industry. 

This is only the beginning of the story of RIM. 

In my next paper I’ll get into a bit more detail about the underlying structure of a RIM Platform and some history of how these structural needs came about.


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