Accelerating RIM Business Value
By Steve Gens, Managing Partner
We start the year with a full research plate featuring our 6th large World Class Regulatory Information Management (RIM) study. This biennium survey has become an industry standard and we work very hard to continually improve the design of the study to deepen what we learn. We look forward to sharing the research broadly with the Regulatory ecosystem as our benchmark practice mission is simple: “Everybody gets better”.
During this past fall, we gathered many of the top minds across industry and the provider sector to review, debate and deepen what we can learn during this research cycle. For industry, 35 organizations representing different product types, company size, and geographic location attended 5 design sessions. We were even able to conduct an in-person session in Copenhagen, with the help of NNIT. Eleven of the top regulatory software and service providers either attended one provider design session or had a 1:1 session with us to share their feedback and insights.
Our final task as a Core Research Team is to determine the right title. In the past, our titles either posed a simple question or focused on where industry was headed:
- 2013 – Managing Regulatory Information as a Corporate Asset (yes, it needs to be!)
- 2014 – What is next Generation RIM and Regulatory Intelligence?
- 2016 – Pursuing World Class RIM: Strategy, Measures, and Priorities
- 2018 – Pursuing World Class RIM: Connections to QMS, Supply Release and Product Change
- 2020 – World Class RIM: Is Industry at a Performance Tipping Point? (again, the answer was “yes”)
For 2022, we toggled back and forth between “accelerating business value” to “what’s next” for the title. We know the majority of regulatory organizations have or are currently going through a major modernization cycle focused on global ways of working, consolidating systems, and better end-to-end processes. The RIM modernization business cases have also shifted towards more revenue benefits (reduce time from first to last market submissions) and higher operational efficiency expectations. We landed on “accelerate business value” to quantify increased performance but will also explore “what’s next” with advanced technology, structured data submission, and cross functionality.
This year, we will dig deeper on organizational dimensions such as cultural impact to performance, emerging roles (data sciences, data stewardship, etc.), and effective data governance practices. On the process layer, we are researching end-to-end process with system-to-system connection priorities and the relationship to business outcomes. Finally, we have our World Class section, which focuses on RIM capability efficiency, business benefit realization, metric programs, cost understanding, global reach, time to information, and data quality confidence along with a substantial update to our detailed regulatory services (outsourcing, reg ops locations, provider satisfaction) and software provider landscape (market share, satisfaction, innovation, and likelihood to change).
We are expecting substantially more small and medium size Life Science organizations to participate this cycle, which will give solid data versus the previous “directional” data for this tier. We continually have 70% of the top 50 participate in this study series.
- RIM is viewed as a mission critical capability similar to ERP, Safety, Clinical, QMS, and finance systems
- RIM is an operational, revenue, and speed enhancer and not just a compliance or “cost of doing business” benefit which is a dated orientation
- RIM data connectivity will reduce life cycle management complexity, especially in the change control and label management processes.
We have so much to learn this cycle and are very excited about fulfilling our benchmark mission: “Everybody gets better”.
Where do you believe the value of RIM is headed?
