Gens Associates

As I was finalizing our 2022 Covid-19 Regulatory Impact Pulse study report this week, I saw a news headline about the UK launching the largest ever 4-day work week trial, to boost productivity. This caught my attention because our pulse study dives into the pandemic impact on ways of working in regulatory organizations where we see shifts in ‘organizational dilemmas’ as people get used to the idea that there will be no true ‘end’ of the pandemic.

If you’re part of our benchmark community, you are most likely aware of our process. However, for those that are new to the research community, the intense data analysis period goes from an all-hands-on-deck QC process to building a massive database and cross-checking calculations, then to spirited debates, the provocation of ideas, and finally, either a confirmation or reevaluation of our hypothesis as we progress towards our findings and insights.

What does strong performance look like for Regulatory Organizations, especially in the new pandemic environment? Have the past 2 years of pandemic trials and tribulations resulted in new innovative practices and further organizational agility? Are companies accelerating business value from their regulatory system and process investments, inching closer to our strong performance and world class levels? There is so much happening that we can’t help but be curious during the most research-rich period of our firm’s history. We have been busy digging into the data to learn what it means for the regulatory community.

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”.

Digitalization has been the major point of focus in much of our client work in the past 18 months, but what does Digitalization even mean? It’s not exactly just a shift away from paper-based manual processes and siloed systems, although that is part of the process. Instead, we view digitization as the natural progression of modernization. As your company evolves, much of the new tools and technologies promises to simply, organize, connect, and automate, well just about anything for everyone on your team.

The long-awaited IDMP/SPOR Version 2 EU Implementation Guide was published in February this year, and if my inbox is any indication, companies all over industry are diving into implementation mode. That old urgency we felt in 2015/2016 is coming back, although this time around it seems to me that, as an industry, we are a bit less frightened and a bit more educated. But understanding conceptually what IDMP is, what SPOR is doing, and what the agency requirements are does not make this implementation easy, or even straightforward.

Surviving a pandemic year, especially in the life sciences industry, means that we all had some rude awakenings. But that’s not necessarily a bad thing. Our 2020 Covid-19 study tells us that crisis often forces us to roll up our sleeves to get things done, often with some new found ingenuity and the realization that a better way might exist.

The life sciences industry is under increased pressure and scrutiny to have accurate real-time data, as more of it becomes public and continuously under regulators lens. At the same time, more internal functions are connecting their key information to gain operational efficiency and obtain regulatory compliance with initiatives such as IDMP / SPOR and EUDAMED.