Steve Gens- Founder, Managing Partner, Gens & Associates
Most major life science companies have spent the past decade modernizing their regulatory information management (RIM) platforms. Now, strategies are evolving to build on this foundation, streamlining processes and enhancing how information is shared throughout the organization and with patients. Founder and managing partner Steve Gens explores the key themes that are emerging from the recent Gens & Associates 2022 World Class RIM Survey.
A decade since we took our first baseline and started tracking companies’ progress and investments in regulatory information management (RIM), we have found that life science organizations’ regulatory operations have achieved much in modernizing the immediate regulatory function globally, and improving their general efficiency through continuous improvement techniques. They have also deepened the strategic partnership with other functions such as clinical, quality, and manufacturing to improve regulatory pathways and expedite new product approvals in all markets; to ensure compliance for existing products; and to harness RIM as an enterprise asset.
Yet there is more work to do, and it’s now that we expect things to get really interesting, building on all the foundational investments of the past decade.
Regulatory pressures, market expectations and more recently the COVID-19 pandemic have cemented and accelerated companies’ transformation ambitions, so that ‘world-class RIM’ aspirations are being geared to a higher purpose. This includes ambitions for connecting regulatory information more seamlessly and usefully with the enterprise as a whole; for improved patient access to the latest product information; and for ensuring all markets have real-time access to the latest regulatory information and intelligence.
Strategic Remit for Regulatory Data
We’re seeing a number of promising themes come to the fore. These include:
- An increasingly strategic remit for regulatory data beyond RA.
- This has organizational implications as functions from Quality and Safety to Manufacturing come to rely more intrinsically on real-time regulatory data flows;
- An evolution of the regulatory organization to encompass data sciences and increase the effectiveness of sharing local regulatory intelligence globally; and
- The emergence of some key indicators of success. These include:
- Data-driven continuous improvement;
- Cross-functional process management for change control and label management;
- Strategic data management and data quality control; and
- A growth in enterprise-level data science expertise to exploit advanced technologies.
Additionally, as end-to-end process transformation becomes a central focus, it’s becoming increasingly clear that innovation will be required at a local affiliate and regional office level to maximize the impact on global performance, quality, and compliance. We call this “the last mile”.
There has been a lot of talk over previous years about the rising role of data as the primary basis for regulatory submissions and general decision-making, rather than static reports or point-in-time regulatory statements about products. Both our 2020 and 2022 World Class RIM benchmarks conclude that the clear shift to data, and the management of data within documents in a more innovation- and resource-friendly manner, is a clear focus by both the industry and many of the health authorities.
The move to a more “data focused” approach comes with investments at an organization level. This is reflected in our 2022 survey of 76 organizations, which sees top performers/those with more advanced RIM activities already claiming to have a higher percentage of key “data” roles within regulatory: data analysts (63%); data governance roles (44%); and a digitalization lead (44%).
Four Pillars of Evolution
So where might all of this lead, and what is the focus strategically? Below is a breakdown of our latest survey findings to how the industry is evolving. At a high level, the new research brings us to four main findings:
1.RIM-related investment looks to the future.
Through a comparison of our 2022 survey findings with those of previous studies we have performed over the last decade, we see a critical mass of biopharmaceutical companies now at the tail-end of a process and system modernization program that started in earnest in around 2013.
Now, to capitalize on their achievements, these companies are shifting their attention and investment toward organizational priorities, advanced technology, and cross-functional information sharing.
2.Digitalization must be strategic.
We see three layers to a comprehensive digitalization strategy: transactional (e.g. robotic process automation, natural language generation etc.); strategic (e.g. data lakes, AI etc.); and foundational digitization capabilities (e.g. master data management). When ultimately these three strands are combined, it should ideally result in a complete set of advanced capabilities to manage and achieve more with regulatory information.
To maximize the potential here, however, companies will need a coordinated strategy that includes regulatory, R&D and the enterprise organization layers. The current tension is that industry and many of the technology providers focus on the transaction to achieve “quick wins”, in the process sacrificing the long-term view and investment portfolio.
3.Focus on Affiliates.
Although it is a strategic priority, most organizations have yet to fully realize global RIM adoption, with just 32% claiming this in 2022 and another 54% still working towards this goal. Even with an increase in end-to-end process work and affiliate access to most global systems, there is a gap in the ability to deliver full-scale process transformation – resulting in tangible improvements to global performance, quality, and compliance.
For this to be possible, innovation will be needed at the affiliate level in the way that local regulatory intelligence is shared globally; in resource allocation via improved submission planning and forecasting; and in improved control of the deviation process for label management. Ultimately, the vast majority of local affiliates are “infrequent users” of RIM systems and processes, so innovation should simplify complex regulatory activities that often require global collaboration and coordination.
4.Culture shift to higher data quality.
As the focus of regulators, of business managers, and of the world at large shifts from creating definitive documents and reports to trusting and working with real-time data, the responsibility for the quality and integrity of that underlying data becomes everyone’s responsibility. Data quality must be an organizational matter, requiring a culture and mindset that values and is committed to ensuring absolute data integrity as an ongoing priority.
In all aspects of associated transformation, innovation must begin with the organization supporting pragmatic experimentation. This is another important cultural shift that will be required, where processes and people’s perception of their responsibilities have previously been much more siloed, fixed and - in many cases – blinkered by functional boundaries and remits.
Intelligent Data Tools
Technology alone cannot deliver the depth and scale of change and improvement that companies are seeking. But in the digital age it is also true that, without optimal application of transactional and advanced technology, teams will be severely limited in their ability to deliver any scale of transformation.
As original product data’s importance grows, and as more of it is used in ‘live’ situations to drive decision-making and complete critical tasks, it follows that intelligent tools to manage, combine, interrogate, and share that data cross-functionally will become ever more critical.
Our research bears that out. Companies are making substantial investments in technologies that fall into each of the categories in our automation classification, suggesting that both near- and long-term objectives are in their automation roadmaps now.
A large proportion of respondents in 2022 reported significant or moderate investments in foundational solutions for master and reference data management (51% and 38% respectively), for instance. We also observed a healthy spread of investments in what we might think of as quite targeted or transactional tools: to automate routine tasks; for author templated content; or to visualize and report on data in new ways (with up to or just over a third of companies actively implementing or looking at a range of the capability categories here).
In our 2022 research we see 39% of companies working toward data hubs; 32% on collaborative submission platforms; 24% on AI/machine learning; 18% on knowledge management; 15% on natural language processing, and 8% on natural language generation. The vast majority are large multi-nationals and mid-tier companies who are actively investigating and conducting proof of concepts with these different types of technologies.
It is no coincidence then that most companies (~75%) have settled on a single-platform strategy for their RIM transactional systems to under[1]pin all of their diverse ambitions, rather than persisting with what could be five to seven different point solutions or best-of-breed applications.
What all of this suggests is that ambitions are growing. Automated document quality checks and document creation are giving way to intelligent search of past health authority responses.
For most companies there is still a way to go with all of this. While the top performers in our survey have largely realized significant speed, quality, real-time information access, reduced complexity, and process integration benefits, most organizations are still at the beginning of that process of extrapolating the fuller benefits of their evolving RIM-based digital process transformations.
Top-Performing Companies
We identified the four main current differentiators of top-performing companies as:
- a clear and well understood regulatory strategy and vision;
- a right-first-time data quality mindset, linked to rewards systems;
- a willingness to try new processes and technologies; and
- a strong willingness and ability to work across functional boundaries.
Leading companies are some way ahead with the planned appointment of strong data skills, as well as regulatory intelligence strategy and analyst roles.
The focus in the coming years will be on extracting regulatory value, by means of increased cross-functional insight and capability. As companies develop ambitions to derive more value from regulatory information, a useful starting point could be to improve information exchange with other functions, reducing operational complexity and enhancing patient outcomes.
Steve Gens is the managing partner of Gens & Associates, a global life sciences advisory and benchmarking firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. Following an early career in industry, across various management positions at Johnson & Johnson, Steve transitioned to consulting and led global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton, before founding Gens & Associates, whose biennial ‘World-Class RIM’ research and pulse surveys track regulatory trends, priority investments, provider eco-system and evolving strategic practices in regulatory information management.
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