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Capitalizing on the modernization of regulatory information management: the next steps

A decade since we began following their Regulatory Information Management (RIM) improvement ambitions, Life Sciences Regulatory Operations has accomplished a lot in modernizing the immediate function globally and improving the general efficiency. They also deepened the strategic partnership with other functions such as clinical, quality and manufacturing – to improve regulatory pathways/accelerate new product approvals in all markets; ensure the conformity of existing products; and operate RIM as a corporate asset.

Now is when we expect things to get really interesting, as the aspirations of “world-class RIM” are geared towards a higher goal. This includes the ambition to connect regulatory information in a way that is more transparent and useful to the business as a whole; for better patient access to the latest product information; and to ensure that all markets have real-time access to the latest information and regulatory intelligence.

So what specific plans emerge? It is clear that the direction of RIM-related investments is changing. A critical mass of biopharmaceutical companies are now at the end of a process and systems modernization program that began in earnest around 2013. Now, to capitalize on their achievements, they are focusing on organizational priorities, cutting-edge technology and interdependence. sharing functional information.

The survey revealed three layers to a comprehensive digitization strategy: transactional (e.g. robotic process automation, natural language generation, etc.); strategic (e.g. data lakes, AI, etc.); and fundamental scanning capabilities (e.g. master data management). When these three strands are combined, it should ideally result in a comprehensive set of advanced features for managing and optimizing regulatory information.

To maximize the potential here, companies will need a coordinated strategy that includes regulatory, R&D and corporate organization levels. The current tension is that the industry and many technology vendors are focused on the deal for “quick wins,” sacrificing long-term vision and investment portfolio.

As working with real-time data becomes the norm, responsibility for the quality and integrity of that underlying data becomes everyone’s responsibility on an ongoing basis. On the one hand, there will need to be a rebalancing of roles to emphasize data stewardship/governance and data science. But, likewise, a data quality/data first mentality must be encouraged on the other side and Between teams, with senior executives advocate for a culture of quality. This helps to ensure that there are no weak links and that critical data can be continuously used as the product’s source of truth.

Achieve global adoption of RIM

While a strategic priority, most organizations have yet to fully achieve global adoption of RIM, with only 32% declaring it in 2022 and 54% still working towards achievement of this objective. 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 process transformation at scale.

For this to be possible, innovation will be needed at the affiliate level in how local regulatory information is shared globally; in resource allocation through better bid planning and forecasting; and in better control of the deviation process for label management. Ultimately, the vast majority of local subsidiaries are “infrequent users” of RIM systems and processes, and the innovation promises to simplify complex regulatory activities requiring global coordination.

In all aspects of the associated transformation, innovation must begin with the organization supporting pragmatic experimentation; teams must also appreciate their responsibilities beyond their immediate function.

Smart tools

Technology alone cannot deliver the depth and breadth of changes and improvements now needed. Yet, without optimal application of transactional and advanced technologies, the potential for transformation will be limited. Intelligent tools to manage, combine, query and share data cross-functionally will become increasingly critical, for example.

As a result, companies are making substantial investments across the full range of automation technologies, suggesting that both short-term and long-term goals are now part of their automation roadmaps.

At the more advanced end of the scale, in our 2022 research, we see 39% of companies working towards 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 multinationals and medium-sized companies that are actively investigating and performing proof-of-concepts with these different types of technologies.

It is no coincidence that most companies (~75%) have opted for a single platform strategy for their RIM transactional systems to support all of their diverse ambitions, rather than persisting with what could be 5 to 7 different advanced applications. . We see it in automated document quality checks and the creation of documents that leave room for smart searching of past responses from health authorities.

Investments are also directed towards intelligent label management; automated extraction of product metadata from RIM systems (so businesses can find it more easily and do more); and smarter resource planning (through pipeline analysis, bid planning, etc.)

For most companies, there is still a long way to go with all of this. While the top performers in the study have largely realized speed, quality, real-time information access, reduced complexity, and process integration benefits, most organizations are still early in this process. extrapolating the fuller benefits of their scalable RIM-based digital process. metamorphoses.

Improving the exchange of information with other functions and reducing operational complexity are among the most immediate opportunities yet to be realized.

Organizational Critical Success Factors

When we focused on where the most successful companies truly move forward from an organizational and cultural perspective, we found these common attributes:

  • a clear and well-understood regulatory strategy and vision;
  • a first-time data quality mindset, linked to reward systems;
  • a willingness to try new processes and technologies; and
  • a strong will and ability to work across functional boundaries.

In terms of roles, leading companies are ahead with the planned appointment of strong data skills, as well as regulatory intelligence strategy and analyst roles.

As leading processors look to the next level of process optimization and more, a whole new chapter is unfolding. A number of clear trends are now emerging as companies look to the next big phase of what we might call Regulatory Transformation+. We can expect a lot of improvements over the next five years to maximize regulatory value. Much of this will be related to better cross-functional understanding and capability, as well as organizational agility. Plus, of course, the continued attention and investment in data quality and related roles and responsibilities. Undoubtedly, RIM-related investments are becoming more strategic and outward-looking as companies build on a solid foundation of RIM modernization.