By Steve Gens

Over the years in developing the Gens and Associates surveys we’ve learned a great deal about developments in regulatory information management (RIM), including what companies are doing and thinking, what they’re concerned about, what they’re planning, and the effectiveness and efficiencies gained from RIM.

Our research has given us insight into what works, what doesn’t, and how best to improve your RIM program. Based on a review of the highest performing companies in our 2014, 2016, and 2018 studies we’ve uncovered three critical areas to achieving improving your RIM.

Our World Class RIM standard weighs highly with data quality confidence as this is core to overall productivity performance. For example, our data shows that high data quality confidence levels of key information assets (registrations, commitments, submission planning, etc.) directly correlates with better “time to report information” and “operational efficiency”.

Many organizations take a major productivity hit because they are constantly “verifying the data” informally at the central, regional, and local level. Having confidence in the data removes those time inefficiencies and improves decision-making. We also know when data quality confidence is high, companies can deliver vital regulatory information in real time or within a day as compared with multiple days or even weeks it typically takes when having to go through data verification processes.

We quantified data quality “verification loops” for three companies (with operations in 85 countries) and found between 6% and 9% of affiliate regulatory time was spent verifying regulatory information because they “did not trust” the information in the global system, such as the registration or commitment data.

Two strategies that work are: having formal data quality audits built into the operational process; and adding quality into personnel goals and objectives (e.g. quality of the registration data) as individual contributions are critical, such as registration data from local affiliates.

Understanding cost does not mean budget management. It means making good economic decisions. Most companies in our benchmark do not have a solid understanding of the total cost of ownership from an information technology and business standpoint. They tend to have a good understanding of the software provider licensing information, but not the internal resource and data remediation cost. It is important in any business case analysis to understand the capability run rate and compare it to any incremental improvement or transformation objectives.

We were also surprised in our latest research to find only 14% of the 69 participating companies understand the cost of doing a regulatory impact assessment (RIA) and the corresponding health authority submission versus the cost/benefit of the proposed manufacturing change. This is a clear pain point with about 30% of the surveyed companies looking to improve their economic understanding of the RIA process in 2019 and 2020.

We have clear evidence from the 2018 study that organizational strategy does make a difference in performance. Having a dedicated RIM group for deploying and maintaining a global system and submission planning makes a tremendous difference to regulatory function success. We also found that reducing the time for health authority submissions and responding to changing health authority requirements was quicker when the local regulatory personnel at the affiliate site reported directly into the global regulatory organization as opposed to a non-regulatory function.4) Gradual process changes versus the “big bang” approach.

Finally, those companies that have good quality, cycle time and volume performance metrics do better with continuous improvement that is vital for process efficiency. These are listed in our autumn 2018 World Class RIM study result whitepaper that you can download from the webiste. Too often the “big bang” approach to process and system change does not realize the intended benefit. Those with a disciplined and “data driven” continuous improvement program increases process efficiency gradually and tend to score higher in our World Class RIM benchmark.

As always, send us a note via our website if you have any questions. We would also be interested in hearing your experiences with your RIM improvement programs.