Beyond RA: the increasingly strategic remit of regulatory data

At Amplexor BE THE EXPERT 2022 we will unveil brand new research into what constitutes world-class and strong operational RIM performance, especially post pandemic, and explore how system and process developments are now giving way to organizational priorities such as data science investment, cross-discipline data governance, & strategic use of AI/automation tools.

June’s BE THE EXPERT event couldn’t be more ideally timed, coinciding as it goes with the publication of our freshest and most poignant research yet into the life sciences industry’s as they  transform their global regulatory information management. By the time we see each other, we’ll have not only the results of our latest World-Class RIM survey hot off the press, but also our follow-up deep-dive into the regulatory impact of COVID-19 on companies’ activities and ambitions.

It’s going to be a lot to unravel, and I think we’re all going to be surprised — and impressed – by some of the findings. As ever, we’ll have some telling trend data as we publish the results of what is now the sixth study in our series since 2013. And while it’s important to be able to compare like with like, we’ve made a point of adding new areas to the study this time too such as changing organization strategies, E2E process priority investments, and revamping of our advanced technology section. We will also drill deeper into the themes that have interested us the most in recent years.

So, not only will we be able to assess how well pharma, med tech, and biotech companies of all sizes are progressing with their data-driven agenda — in terms of systems and processes — relative to their peers (and we will see new entrants to the World-Class RIM league table this time); we will also start to build a picture of how companies are adapting organizationally. That is, we will learn more about how they are rebalancing skill sets, putting in place cross-functional capabilities (as Regulatory data becomes more interconnected with Quality, Safety and Manufacturing, for instance), and establishing deeper ‘data science’ expertise – as the quality and reliability of regulatory data, and how this is managed and improved, becomes a growing priority.

The COVID effect: from crisis to recovery to renewal

In the fall of 2020, six months into the pandemic, we took our first empirical and qualitative look at how COVID-19 was affecting regulatory information management and companies’ ambitions for transforming this. At that point, we surveyed 280 individuals from 52 diverse companies. Eighteen months on, we went back to those same organizations with a follow-up survey, quizzing some 180 individuals this time about any intervening developments and changes of focus. That survey closed just days ago, and we’ll be consolidating and analyzing the findings just in time for presentation and discussion at this year’s BE THE EXPERT.

We’re especially interested to see the influence of lockdowns, supply-chain challenges, and product shortages on companies’ momentum (and prioritization) around digitally transforming their regulatory information management, preparation and tracking. Also its impact on their interest in, and take-up of, advanced technologies – including artificial intelligence and regulatory process automation tools as processes become more integrated and streamlined across departmental boundaries (provided the underlying quality of data is dependable).

When we first embarked on this tranche of research nine years ago, we noted that this would be a decade of regulatory transformation — little knowing that a global pandemic would increase the associated sense of urgency, and cement a strategic shift in regulatory operations and associated information management.

Now that a growing majority of companies have straightened out the foundational enablers (the platforms across which to manage data more effectively), priorities are evolving toward the organizational factors that now need to be honed, and the latest findings should give us some useful indications about where companies are making most progress, where they are looking for next-level transformation, and where they are hitting obstacles.

Looking right across the industry, as well as the activities and performance of regulatory software and service providers, and the evolving interests of the health authorities, we’ll be able to build our best picture yet of practices that are now changing forever as each of these stakeholder groups reimagines the role and value of the regulatory function.

I do hope you’ll join for what will surely be another lively and illuminating session! Please register here!

About the author

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

 His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.