Steve Gens- Managing Partner, Gens & Associates
Achieving regulatory excellence in life sciences companies depends on a combination of process optimization, effective global systems, high data quality, and better affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment.
Yet highly manual processes, specific local market requirements, and tool usage inconsistencies have often meant a gap in global information visibility and flow which adds risk to key regulatory processes.
This is the subject of important new research we have just published at Gens & Associates. It is the most comprehensive report available to date looking at the evolving role and importance of local affiliates in efforts to make global regulatory processes more consistent and effective through optimized systems and tools.
These processes include submission forecasting and planning; product registration management; health authority interactions and commitment management; local label management; submission content management, and archiving; regulatory intelligence management; and promotional material management.
Continued Use of Regional Tools
Our new research includes detailed feedback from 320 local offices/ affiliates representing 94 countries. The affiliates represented 20 sponsor companies, most of which provided between 10 to 25 contributing affiliates of varying sizes and geographic locations to participate in the research.
We started some limited affiliate research in 2013 and have been charting various aspects of affiliate operations in managing regulatory information as part of our World-Class RIM study program for around a decade. This has enabled us to compare the current findings with a baseline, and we have determined that companies are now roughly halfway to achieving a strong level of operating performance from a local affiliate perspective. For example, many companies are striving to reduce the time from first market to last market regulatory submission by 50% (cutting 9-12 months from this critical cycle).
As things stand, 52% of the time spent by affiliates on managing their regulatory processes continues to involve the use of local and regional tools, in addition to or instead of global authoritative systems. The fact that 48% now use centrally designated platforms is encouraging and represents a significant improvement on the 13% reporting the same back in 2015. However, there is still clearly work to be done to streamline operations. As long as affiliates continue to default to manual processes, spreadsheets, and local file shares to manage their information and documents, there will be inefficiencies both locally and centrally.
Smaller Affiliates Feel Overlooked
Even when new system capabilities have been extended to local affiliates, the benefits aren’t always felt. In the current study, almost a third of affiliates say recent system and process investments have failed to improve their situation. In other words, they continue to struggle with their ability to use global RIM systems and efficiently manage regulatory information for both local and global consumption. Part of this dynamic is due to the vast majority of local affiliates being “infrequent users” of the global capabilities (e.g., use them once a week, not every day). One of their common requests was tailored and simplified training (from a local affiliate point of view) so that increased competency of the global capability could be realized.
Affiliates of all sizes share a strong desire to be more integrally included in global regulatory capability process design, resource planning, system enhancement prioritization, and overall governance.
One of the most striking findings is that smaller affiliates feel most acutely overlooked when it comes to inclusion in terms of system and process optimization being tailored to their needs. Most companies request local affiliate participation from the larger affiliates as they are more likely to have the resources to support global initiatives. This brings “bias” to the local affiliate needs as often the small offices have individual resources doing both regulatory, quality and safety activities. If such concerns were addressed, they would be able to more easily and efficiently comply with internal global RIM expectations set by the central organization.
Desire for Greater Simplicity
Based on our estimates, Life Sciences companies have collectively spent some $1.9 billion over the last five years on global RIM modernization at a system and process level. Yet up to now, they have not achieved the desired 360-degree transformation. What’s needed is the next leap in delivering end-to-end regulatory information management from a cross-functional standpoint. But this will require that more affiliate feedback is incorporated as part of new enhancements – both to vendors’ software and more critically, to internal processes.
The study asked “What one investment would affiliates like to see improved about regulatory information management”; they most commonly responded they wanted greater simplicity. This reflects a view there are still too many steps to locate information or complete tasks as the top three “simplification” themes were better-integrated systems, improved system usability/training, and simplified processes/role clarity. The current complexity impacts common daily tasks but has a much greater impact on critical processes such as label compliance, tailoring core submission packages, and managing variations.
Also, a lot of time is being spent on data and content verification which greatly reduces productivity and “time to health authority submission”. Striving for a single, effective, authoritative source of truth remains a core goal for most regulatory organizations, to maximize the ROI of global RIM investments.
How to move forward? When we scored companies on their global RIM capability including affiliate contribution, only one company qualified as a ‘strong’ performer. What was interesting to the research team is that 16 of the 20 companies’ performance scores were very close which implies most companies share the same challenges and opportunities. Progress is being made; however, we are not yet at a stage where there is a definitive ‘best practice’ emerging for affiliate inclusion.
Improving engagement with affiliates requires structured communication and transparency. Where affiliate requests cannot be accommodated, for instance, it is a good idea to communicate the reasons back to affected users to validate their input.
To ensure that affiliates genuinely feel heard, recommendations from our study include more proactive creation of incentives to move away from local workarounds and good data governance. Improving the usability of global tools to be more affiliate-specific will also help to cultivate buy-in and reduce risk to key regulatory processes.
For software and service providers, as well as for central regulatory teams, the message is to be more proactively inclusive in bringing affiliates into feedback loops and into future process and system development. This should also involve discerning the differences in the needs of very small affiliate teams (e.g., with under 5 people), and larger in-country teams. Conducting a ‘day in the life of’ fact-finding activity would go a long way here. Optimized processes and solutions could then be adapted intelligently so that only the relevant fields are presented to the local affiliate.
A white paper on the wider theme will be published next year.
Steve Gens is the managing partner of Gens & Associates, a global life sciences benchmarking and advisory consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. Email [email protected]. www.gens-associates.com
Publication Details
This article appeared in Pharmaceutical Outsourcing:
Vol. 4, No. 24
Oct/Nov/Dec 2023
Pages: 26-27
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