Life Science Organisations to Deliver Regulatory Information Management to Local Affiliates

New research has revealed that Life Sciences local company affiliates are often marginalised in the endeavour to transform to more efficient global regulatory information management (RIM). Steve Gens of Gens & Associates discusses how a renewed focus on affiliate operations can contribute to resolving data gaps and eliminate inefficiencies within the processes.

Local affiliates are vitally important when it comes to efforts to make global regulatory processes more consistent and effective through optimised systems and tools. Yet many affiliates are commonly still using some manual processes, and along with tool usage inconsistencies, there is a real danger of creating gaps 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.

Research from Gens & Associates has revealed the current issues faced by affiliates, based on 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. Gens & Associates started some limited affiliate research in 2013 and have been charting various aspects of affiliate operations in managing regulatory information as part of our RIM study program for around a decade.

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 enhancements – both to vendors’ software and more critically, to internal processes.

Based on our recent research, we have determined that companies are now roughly halfway to achieving a strong level of operating performance from a local affiliate perspective. One improvement in operating performance can be seen as 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).

Focus Still on Local Tools

Currently, 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.

So there remains further 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.

Demand for simplicity

When we asked affiliates “what one investment would affiliates like to see improved about regulatory information management”; they most commonly responded they wanted greater simplicity. Even when new system capabilities have been extended to local affiliates, almost a third of affiliates say this has failed to improve their operations. They continue to struggle with their ability to use global RIM systems and efficiently manage regulatory information for both local and global consumption. This is largely because affiliates are infrequent users of the global systems and there are still too many steps to locate information or complete tasks.

In addition, 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 organisations, to maximise the ROI of global RIM investments.

Bring Affiliates into Feedback Loops

Most companies appear to share the same challenges and opportunities – 16 of the 20 companies’ performance scores were very close. When we scored companies on their global RIM capability including affiliate contribution, only one company qualified as a ‘strong’ performer. Clearly, we are not yet at a stage where there is a definitive ‘best practice’ emerging for affiliate inclusion – and software and service providers, as well as central regulatory teams, must more proactively bring affiliates into feedback loops and into future process and system development.

This should also involve responding to the differences in the needs of very small affiliate teams (e.g., with under 5 people), and larger in-country teams. Smaller affiliates feel most 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.

Carrying out 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.

Structured feedback methods and incentives are both useful tools to drive affiliate engagement. 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. This also enforces the feedback loop for all parties. Aside from more formalised feedback loops, to ensure that affiliates genuinely feel heard, recommendations from our study include more proactive creation of incentives to move away from local workarounds, good data governance, and improving usability of global tools to be more affiliate specific, will help to cultivate buy-in.

Opportunity to Benchmark Progress

The affiliate study offers companies a means to keep benchmarking themselves against the findings as they proactively work toward World-Class Global RIM. A white paper on the wider theme will be published next year.

A combination of process optimisation, effective global systems, high data quality, and improved affiliate collaboration will support pharmaceutical manufacturers as they navigate the regulatory landscape and progress towards enhanced global regulatory information management.