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News & Views

World class RIM study

Leading Life Science benchmarking and advisory firm Gens & Associates ( launches its largest World Class RIM℠ Benchmark study and invites stakeholders across the global Life Sciences industry and regulatory provider community to play their part in cementing the ultimate approach to regulatory information management (RIM).

The 2024 global study of Life Sciences regulatory information management programs – the 6th in the firm’s World-Class RIM series (which dates back to 2015) – will be the deepest dive yet into hot topics such as structured data submission programs, advanced technology application to key regulatory processes, and regulatory digitization strategies.  

“This important new research will be the largest, broadest and deepest study we have done to date, in terms of the participants and our outreach to include more companies of different sizes and origins.  Inclusivity is paramount, as the whole aim of this research program is to empower everyone to improve the performance of their regulatory information management program (and for the providers, of their products and services), by harnessing the latest leading practices and supporting tools,” explains Steve Gens, Founder and Managing Partner, Gen & Associates.

Expecting to attract record-breaking participation from 80-100 organizations from all corners of the Life Sciences industry, including small startups in the clinical stage, biotechs, medtech, generic, consumer, and combination product companies, as well as traditional pharma organizations, the 2024 survey will help define and hone the industry standard for ultimate regulatory information management.

“Our mission at Gens & Associates is ‘Everybody Gets Better’ – by which we mean everyone across the regulatory ecosystem (industry players, IT/service providers, and health authorities),” continues Gens.  “That same philosophy is also at the heart of our World Class RIM Benchmark study.  The more companies that are involved in the design of the study, and the more survey participants we attract, the more powerful the actionable insights that everyone can draw on.”

Gens & Associates estimates that over the last five years, Life Sciences companies across the world have collectively spent over $1.9 billion on improving regulatory information management.  The latest study will explore the impact of that investment, for instance in tangibly transforming organizations’ regulatory intelligence and cross-function process efficiency.

Companies participating in the new study will gain access to this latest industry-recognized RIM research (typically running to 100+ pages) into key trends and practices; in addition to insights into their own performance position relative to their industry peers and the latest observed World Class RIM performance levels.  They will also benefit from actionable insights, and a detailed view of the current status and emerging trends across the Regulatory software and service provider landscape.  

There is no cost to take part in this blind study.  In addition to receiving the full results, participants can be part of a community debrief.  First-time survey participants are invited to watch a short video covering Gens & Associates’ benchmark history and value, the 2024 study focus, as well as research policy and rules.

For more information see
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