AI in Regulatory Information Management: Where Are Companies Betting Their Budgets?

As Gens & Associates collates and begins to analyse fresh new findings from its latest World Class RIM Research, Steve Gens speculates about the industry’s top priorities for the next 3-5 years

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As Gens & Associates collates and begins to analyze fresh new findings from its latest World Class RIM Research, Steve Gens speculates about the industry’s top priorities for the next 3-5 years

With perfect timing given the approach of this year’s BE THE EXPERT event, we’ll soon be collating the final results of this year’s World Class RIM Research – a regular international study which digs deep into the trends, hopes and priorities of life sciences firms’ investment in regulatory information capabilities.

This year we’ve had a bumper response, from around 70 companies (compared with 54 firms in our previous study), including a much larger proportion of smaller organisations as well as medical device suppliers.

Beyond blue-sky thinking: pinning down AI ambitions

In addition to providing a barometer to measure changing priorities compared to previous years, this latest study will provide new insight into companies’ attitudes to emerging technologies such as artificial intelligence and robotics. We have sought to get behind the blue-sky thinking to determine whether and when companies plan to invest, and in relation to which specific use cases.

As the survey results come in, we have an inkling of what to expect against some of these questions – for instance, we suspect we will see AI activity related to manufacturing and the product change control process along with regulatory intelligence. But we’re also anticipating some surprises and some unprecedented insights into where the proof-of-concepts are emerging, and who has practical ambitions for AI in the near future.

We anticipate evidence of a progression towards a new generation of RIM. Over the last five years or more, companies have been largely focused on stabilising their regulatory information management environments. They’ve been working towards a global capability, for instance, and raising the level of data quality - to enable more confident conclusions and decision-making.

Deeper data connections

The focus now is improving connections between regulatory activities and other functions, from supply release and product change control to clinical and quality management systems. The ideal that firms need to work towards is an end-to-end RIM platform, with close integration and extended visibility. This will be the key to improved data flow, measurement, automation, and continuous improvement – leading to higher efficiency and productivity. Once core systems are in a good place, we predict this will be the primary focus for companies over the next 3-4 years.

And it’s this kind of vision that will unlock budgets. ‘Compliance’ alone no longer makes for an adequate justification for new spending.

But let’s see what the survey throws up. What we can promise you is some invaluable trend data, and deeper insight into the issues and opportunities that currently preoccupy those responsible for making strategic RIM-related decisions.

From my own perspective, I’m looking forward to getting among people in their different roles at life sciences companies, as they share their latest stories. BE THE EXPERT is always a welcome date in my diary – the event is unfailingly stimulating, well structured, and is a great learning environment. And with its stunning setting on the Adriatic coast, we can bet on some great views too.

Steve Gens is a managing partner at research & consultancy firm Gens & Associates. At June’s BE THE EXPERT event in Dubrovnik, he’ll be presenting and discussing highlights from this year’s global World Class RIM Research under the session heading Evolution of Regulatory Information Management: Past, Present and RIM2022 Predictions.


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Published on    Last updated on 01/07/2019

#Life Sciences, #Artificial Intelligence

About the author

Steve has over 25 years of experience, primarily in the biopharmaceutical and healthcare industries. After leading many technology and business process initiatives for Waterford Crystal and Johnson and Johnson, he developed an interest in global teams and organizational performance. He moved into consulting where he built and managed several healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. Steve has deep strategy formulation, organization development and performance, global workplace collaboration, industry benchmarking and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science and a Master of Science in Organization Development with distinction for his field work from American University. He is certified in Change Management from the NTL Institute of Applied Behavior and is a frequent speaker with several publications.


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