Fostering effective Life Science affiliate collaboration for global regulatory process optimisation

Achieving regulatory excellence in Life Sciences companies depends on a combination of process optimisation, 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.

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.

Feedback from affiliates worldwide

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 size and geographic location 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.

As things stand, 52% of the time spent by affiliates on managing their Regulatory processes continues to involve use of local and regional tools, in addition to or instead of global, authoritative systems. The remaining  48% of time is now used in centrally designated platforms which is encouraging, and represents a significant improvement on the 13% reporting the same back in 2015. Clearly there is still work to be done to further streamline operations.

Affiliates not maximising capabilities

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 can be realised.

Affiliates of all sizes share a strong desire to be more integrally included in global Regulatory capability process design, resource planning, system enhancement prioritisation, 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.

Based on our estimates, Life Sciences companies have collectively spent some $1.9 billion over the last five years on global RIM modernisation 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 revealed that affiliates believed there are still too many steps to locate information or complete tasks. The top three “simplification” themes were better integrated systems, improve system usability / training, and simplify processes / role clarity.  The current complexity impacts common daily tasks but has a much greater impact in critical processes such as label compliance, tailoring core submission packages, and managing variations.

Global RIM capability

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.  

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. Optimised processes and solutions could then be adapted intelligently, so that only the relevant fields are presented to the local affiliate.

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.

While progress is being made, there is not yet definitive best practice emerging for affiliate inclusion. The affiliate study offers companies a means to keep benchmarking themselves against the findings as they proactively work toward World-Class Global RIM.