Steve Gens shares his thoughts on what’s to come in RIM. Catch his keynote speech in our virtual BE THE EXPERT event.
As the industry strives to progress its Regulatory Information Management (RIM) capability to an enterprise level, it requires changes to the process, system, and organizational levels. For some companies, it is an incremental change, while for others, it is truly a modernization effort. Our biennial World Class RIM Industry Survey tracks the rapidly evolving and increasingly critical elements in the global picture for increasing the productivity, efficiency, and agility of Life Sciences organizations.
As companies get the quality and consistency of their regulated product data in order, and shore up their data governance and continuous data improvement strategies, many are turning their attention to the potential for connecting RIM systems with clinical systems, product supply release (ERP) systems, product change control, safety/pharmacovigilance, labeling systems and more.
At this year’s virtual Amplexor BE THE EXPERT event, I’ll be presenting the latest evidence of this – and of the benefits companies expect or are already seeing – in the form of our most recent World Class RIM Industry Survey – for 2020 – the results of which are hot off the press.
World Class RIM has gone global and is within reach
Given everything going on in the world currently, we’re delighted to report a record response to this year’s survey with nearly 70 companies participating in phase 1. We are keeping the research open over the summer to support companies that intended to participate but could not. We are also expecting more new organizations to benefit from our research. We’ll be sharing how RIM has progressed from our World Class studies of 2016 and 2018 along with providing a clear picture of where this critical capability is heading over the next 5 years.
The range of companies covers the full spectrum too, with 45 per cent of respondents coming from smaller life sciences organizations striving for agility and scale, while the priority for large multinationals and mid-tier companies tends to be simplification and harmonization of complex and unwieldy RIM landscapes.
We are in the final analyses of the data and the preliminary signs are very encouraging. We had already seen an improvement in RIM-related performance from 2018, especially in the data quality, time to report information and efficiency areas. We have even seen companies cross into the ‘world-class’ category – which is an impressive feat!
Joining the dots: Regulatory moving towards enterprise connectivity and information throughout
The really interesting part this year will be the quantification of business benefits, not least as companies start to join the dots between RIM and other systems across the life sciences enterprise. After all, the hoped-for transformation of processes isn’t – or certainly shouldn’t be – confined solely to Regulatory; it should be extended to enable cross-functional process optimization in end-to-end label management, variation management, or the execution of global dossier strategies, to name a few. Encouragingly, the survey data suggest that up to 80 per cent of life sciences organizations are starting to work and progress on these kinds of improvements and are continuously honing processes to make better use of resources, increase speed of delivery, and reduce risk.
This year’s survey will also reveal the level of experimentation/proof-of-concept initiatives with advanced technologies including AI, robotics and natural language processing as a means of further optimizing – and at least partially automating – high-volume administrative activities.
There are a lot of fascinating insights to unpack, and I look forward to sharing and discussing the highlights with you on May 27.
Steve’s session at Amplexor’s virtual BE THE EXPERT forum, being hosted online between Tuesday 26 May and Friday 29 May, opens proceedings on Wednesday 27 May. It’s titled “2020 World Class RIM Industry Survey – Where are Companies Innovating?”
Steve Gens
About the author
Steve Gens is the managing partner of Gens and Associates, a global life sciences consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance.