Are RIM Investments resulting in better operating performance and business value?

By Steve Gens MSOD

Part of our 2022 World Class RIM study of 76 organizations is the investigation of business value realization and the tracking of 16 business benefits. The majority of industry has made or is currently making significant investments to modernize and globalize their key regulatory processes and systems. The RIM modernization cycle started around 2013 with high expectations to increase regulatory operating performance and strategic value globally.

This year’s study is our 6th major RIM study since 2013. We developed the World Class RIM standard with the help of 35 companies in 2015; it comprises of 3 value categories that have different weightings to determine a company’s performance and peer comparison.

  • 1.)  Operational Performance consists of the efficiency of our 15 RIM capabilities, the maturity of RIM connections to other functional systems (e.g. QMS, ERP, eTMF etc.), time to report key regulatory information (real time to several weeks) and the confidence in the quality of data in key systems.
  • 2.)  Business Benefit outcomes focus on the 16 benefits we track and if an organization has fully realized, partially achieved, or planning to achieve them in the next 2 years.
  • 3.)  Foundational value comprises of the effectiveness of their metric and continuous improvement program, the usage of 34 KPIs (volume, cycle time, and quality), understanding cost, and if they have a true global RIM capability (global reach).

The good news is RIM efficiency has increased steadily since 2016 with a 17% increase since 2020. Submission Production, Submission Content Management, and Ad/Promo lead the way with the highest efficiency ratings while Health Authority Interactions (Q&A process) had the largest efficiency increase (25%) since 2020. The number of companies realizing real-time regulatory information has increased from 37% in 2020 to 43% this year and a significant jump in affiliate access to global RIM systems moved form 30% in 2018 to 57% this year.

While this is great news, industry continues to struggle with achieving high confidence in the quality of information in key systems. When confidence is low or moderate, it causes significant verification loops that directly impact regulatory productivity, especially at the affiliate level. The high confidence level is only at 38% for all participants while our top performers (those that achieved World Class or Strong Performance levels) achieved a 66% high confidence level.

Our 16 Top Performers also have achieved significant business benefits which provides a clear opportunity for those companies that aspire to improve performance.

The top business benefits fully realized or partially achieved were:

  • Access to real-time information (94%)

  • Increase data quality in regulatory authoritative sources (94%)

  • Speed to respond or react to a regulation change (94%)
  • Reduce level of operational complexity (88%)
  • Better integration of business processes (88%)
  • Improve outcomes of an audit or health authority inspection (88%)
  • Increase use productivity / efficiency (88%)

The regulatory function is incrementally improving its operating performance, especially large and mid-tier organizations (defined by revenue). Smaller organizations are more focused on scale so their business benefit profile is different than the large multi-nationals.

We expect significant increases in data quality confidence with the current focus and investment in data governance, reference data management, and master data management. We also expect a significant jump in global RIM adoption over the next two years.

What type of business benefits is your regulatory organization achieving? Please reach out if you’re working on your business case to understand how other organizations in our benchmark achieved strong business benefit results.