Highly manual processes, specific local market requirements, and tool usage inconsistencies have impeded global information visibility and flow, adding risk to key regulatory processes. More effective collaboration with local affiliates is key to addressing this. Steve Gens of Gens & Associates analyses new research that reveals the challenges facing Life Science organisations and offers some practical solutions.
Process optimisation, effective global systems, high data quality, and better affiliate collaboration are key to meeting regulatory requirement in the life sciences sector. Gens & Associates has revealed new research looking at the evolving role and importance of local affiliates in efforts to make global regulatory processes more consistent and effective through optimised systems and tools.
Regulatory 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.
The research includes detailed feedback from 320 local offices and 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.
Central platforms
Gens & Associates has 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 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. Yet, while 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.
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 optimisation 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 organisation.
Simplicity is key
However, almost a third of affiliates say 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.
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 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.
Affiliates told us they wanted greater simplicity and that 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.
Too much 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 organisations, to maximise the ROI of global RIM investments.
Best practice for affiliate inclusion
We are not yet at a stage where there is a definitive ‘best practice’ emerging for affiliate inclusion though progress is being made. 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. There is a pressing need for software and service providers, as well as central regulatory teams, to be more proactive in bringing affiliates into feedback loops and into future process and system development.
Practical approaches to this might include discerning the differences in the needs of very small affiliate teams and larger in-country teams, perhaps by conducting a ‘day in the life of’ fact-finding activity. Optimised processes and solutions could then be adapted intelligently, so that the local affiliate only sees relevant fields.
Improving engagement
The affiliate study offers companies a means to keep benchmarking themselves against the findings as they work toward World-Class Global RIM. A white paper on the wider theme will be published next year.
In the meantime, structured communication and transparency is key to improving engagement with affiliates. Alongside formalised feedback loops, recommendations emerging from the study include improving the usability of global tools to be more affiliate-specific, good data governance, and creating incentives to move away from local workarounds towards adopting centralised practices.
