By Steve Gens, Gens & Associates
A decade since we started tracking their ambitions for improving regulatory information management (RIM), life science regulatory operations have achieved much in modernizing the immediate function globally and improving general efficiency. They have also deepened the strategic partnerships with other functions such as clinical, quality, and manufacturing to improve regulatory pathways/expedite new product approvals in all markets, ensure compliance for existing products, and harness RIM as an enterprise asset.
It’s now that we expect things to get really interesting, as “world-class RIM” aspirations are geared to a higher purpose. This includes ambitions for connecting regulatory information more seamlessly and usefully with the enterprise as a whole, improving patient access to the latest product information, and ensuring all markets have real-time access to the latest regulatory information and intelligence.
So what specific plans are emerging? Our latest research via our 2022 Word Class RIM Survey of 76 leading life science organizations yields four main findings:
1. The Focus Of RIM-related Investment Is Shifting.
A critical mass of biopharma companies is now at the tail end of a process and system modernization program that started in earnest around 2013, when Gens & Associates began consulting and surveying on RIM. Now, to capitalize on achievements, companies are shifting their focus toward organizational priorities, advanced technology, and cross-functional information sharing. We see the medtech sector about five years behind the biopharma sector in global RIM adoption and modernization plans.
2. A Clear Digitalization Strategy Is Needed.
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 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, 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,” sacrificing the long-term view and investment portfolio.
3. Local Affiliate Focus: Last Mile Innovation Is Needed Now.
Although 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 toward 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.
For this to be possible, innovation will be needed at the local 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, and innovation promises to simplify complex regulatory activities requiring global coordination.
4. Mindset Matters: There Needs To Be A Culture Geared To Higher Data Quality.
As working with real-time data becomes the default, the responsibility for the quality and integrity of that underlying data becomes everyone’s responsibility, and on an ongoing basis.
On the one hand, there will need to be a rebalancing of roles to emphasize data custodianship/governance and data science. But, equally, a data quality/data-first mentality needs to be fostered across and between teams, with senior leaders advocating for a culture of quality. This is to ensure that there are no weak links and that pivotal data can be continuously relied upon as a source of product truth.
In all aspects of associated transformation, innovation must begin with the organization supporting pragmatic experimentation; teams must also appreciate their responsibilities beyond their immediate function.
Advanced Technology’s Role
Technology alone cannot deliver the depth and scale of change and improvement now needed. Yet, without optimal application of transactional and advanced technology, transformation potential will be limited. Intelligent tools to manage, combine, interrogate, and share data cross-functionally will become ever more critical, for instance.
It follows that companies are making substantial investments across the full range of automation technologies, suggesting that both near- and long-term objectives are in their automation road maps now.
At the more advanced end of the scale, 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 Growing Importance Of Capability Cohesion
It is no coincidence that most companies (~75%) have settled on a single-platform strategy for their RIM transactional systems to underpin all their diverse ambitions, rather than persisting with what could be five to seven different best-of-breed applications. Additionally, we see strategic decisions being framed around cross-functional platform lines, meaning having clinical, regulatory, quality, and safety on a common platform.
Investments are shifting, too, toward intelligent label management, automated extraction of product metadata into RIM systems (so companies can find it more easily and do more with it); integration of the Clinical Trial Master File (eTMF), quality management system, and product lifecycle management for the device sector; and smarter resource planning (through the analysis of pipelines, submissions planning, etc.)
Plenty To Reach For
For most companies, there is still a way to go with all of this. While the study top performers 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.
Improving information exchange with other functions and reducing operational complexity are among the most immediate opportunities still to be fully realized with strategic focus on clinical, quality, and commercial connections for both the biopharmaceutical and medtech sectors.
When we homed in on where the top-performing companies are really striding ahead from an organizational and culture perspective, we found these common attributes:
- 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.
Role-wise, leading companies are ahead with the planned appointment of strong data skills, as well as regulatory intelligence strategy and analyst roles.
No one can be sure what the future will hold, but we can expect a lot of refinement over the next five years to maximize regulatory value. Much of this will be around increased cross-functional insight and capability, as well as organizational agility. Plus, of course, there will be continued focus on and investment in data quality and related roles and responsibilities.
In the meantime, we’ll keep tracking developments.
About The Author:
Steve Gens is the managing partner of Gens & Associates, a global life sciences advisory and benchmarking firm focused on the regulatory ecosystem. He consults with life science organizations experiencing significant growth and transformation. He can be reached at firstname.lastname@example.org.