Gens Associates

Managing regulatory intelligence information and delivering the broad variety of services expected of regulatory intelligence departments continues to be a challenge for the biopharmaceutical industry. The Gens & Associates 2022 Regulatory Intelligence Industry Survey (n = 42) identified the degree of technology support for ten specific use cases. The survey also explored the level of automation being applied to core activities carried out in regulatory intelligence programs.

Almost exactly a year ago, EMA announced a U-turn on its IDMP/SPOR implementation plans: they set aside the expected requirement to prepare FHIR messages to accompany eCTD submissions in favor of a plan to collect structured data using the planned DADI web-based electronic application forms.

In recent months, the concept of a Regulatory Center of Excellence (CoE) keeps popping up in conversations with our clients and research community. It’s happened often enough for our core team to wonder if Regulatory CoEs develop into a leading organizational strategy as a way to better support regulatory organizations as they continue to evolve. And if so, how does it develop and what could it accomplish?

As the Gens & Associates Research Team has pointed out in the latest World Class RIM Survey, we are nearing the end of the latest RIM Transformation Wave. There is no doubt that this investment wave over the last decade has consumed a significant amount of the total dollars available to invest in Regulatory technology, with another significant portion being spent on the ever-evolving IDMP requirements including several false dawns.

We have learned “what works to improve performance” from our extensive regulatory information management (RIM) research and client projects with over 120 organizations. Since our 2014 RIM benchmark study and for each RIM survey since, there is no correlation between top performers to any one software provider or system strategy; top performers excel at process and organizational work along with strong implementation execution.

The biggest challenge to finalizing our extensive World Class RIM research is the core research team aligning on four key insights which takes several weeks of debate. This research cycle, “Solving the Last Mile” or “additional innovation required at the affiliate level” was deemed critical to improve the overall performance of most regulatory divisions.

The past few weeks, we’ve shared our thoughts on accelerating business value realization, aligning on a digitalization strategy, data quality sustainability, and the impact of culture for an organization…and what those all have in common is the need for people and skillsets to accomplish the work.

One of the key components of the World Class RIM rating is data quality confidence. Confidence in data quality is an indicator of the true effectiveness of regulatory processes and systems – if an organization has confidence in its data, it means the processes and capabilities supporting the management of that data are strong and trusted by the organization.