Gens Associates

Imagine a world where metrics can identify issues before they occur, where forecasts are accurate, and stakeholders can perform effectively and grow in their jobs thanks to full process transparency. And imagine that these dashboards are automatically populated, forecasting models automatically updated, periodic reports automatically generated, and issues automatically identified and reported. We need not rely upon artificial intelligence, simply using the data and metadata within our systems (see figure below) can provide the insights to effectively manage and continuously improve regulatory performance.

A key headline from the 2022 WCRIM Study highlights the need to optimize engagement at the affiliate level in order to ‘solve the last mile’ in terms of achieving global RIM operational performance, high data confidence levels, quality, and compliance. Because of all these high value components, we know this is an important topic for many organizations.

2022 seemed to have gone by especially fast with the relaxing of covid restrictions, more in-person interactions, and even a flight or two for some. For the G&A Team, we’ve had our most research-intense year yet.

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.