Across pharma Clinical, Regulatory, Quality, and Pharmacovigilance operations, ever more ambitious process digitalisation, and a drive towards “data-first” activity, is heaping the pressure on teams to conform to strict new data input and reporting conventions, among other requirements. Digital adoption platforms (DAP) – tailored instructional overlays to cloud-based systems – can be invaluable for compliance, adding step-by-step guidance on exactly what’s required at each point. MAIN5’s Sabine Gölden explains.
Across the modern pharma organisation, overstretched clinical, regulatory, quality, and pharmacovigilance teams are rapidly becoming overwhelmed by the multiplying digital processes and IT systems they are required to use. The systems are increasingly sophisticated and complex, too, reflecting the latest tech capabilities and the rapidly-evolving regulatory requirements they map onto.
For teams to fully harness the potential of these advanced systems (e.g. next-generation regulatory information management systems, quality management, or safety systems), they must first know how to use them correctly. More often than not now, that requires more than designated upfront training then habitual system use. That’s if teams are to use new capabilities confidently, reliably and in a compliant manner.
It is for this reason that digital adoption platforms (DAP) are gaining traction in a pharma GxP compliance context, guiding users for instance in exactly how to input data at each step of a process via a series of handy in-app prompts. These platforms sit on top of cloud/web-based IT systems. These online overlays to target applications help to steer users through tasks such as form-filling and data entry, nudging the desired action at each stage, such as how to format data correctly, or adhere to a particular naming convention. DAPs can halve the investment needed in regular training, or e-learning materials creation; the same with post-go-live helpdesk support, say the main vendors.
An asset many companies already have
DAPs are already proven in centralised business functions like HR, where they have been shown to significantly boost user adoption of important applications such as Workday (total DAP spend was worth $621.5 million in 2023, and is forecast to reach $3.86 billion by 2032[1]).
This existing enterprise use means that many companies will already possess DAP licences. Extending the reach of those platforms would simply involve developing suitable materials for each new respective application.
DAPs can have a particular impact where users are faced with sophisticated systems, or those with complex features. In pharma clinical, regulatory, quality, and pharmacovigilance functions, their potential is significant. The current transition from document-based operations and health authority exchanges to data-driven decision-making, and the need to conform with comprehensive new and expanding standards such as ISO IDMP, compound the need to use new or updated systems correctly and to input good data reliably and consistently. Upfront training alone won’t ensure that individuals consistently conform to agreed naming conventions or data structures when inputting critical information. Use of DAPs/in-app prompts can drive a minimum 20% improvement in data accuracy[2].
Administrative considerations
DAPs do not touch or interact with a system’s data, which means they don’t present a new risk to security or data protection. Because the platforms are an overlay, they are infinitely agile and adaptable too. Where traditional e-learning materials often rely on liberal use of screenshots to highlight what to do where (soon rendered out of date as systems, fields, or data requirements are updated), DAPs can be readily amended on the fly. Given how frequently cloud applications can be refreshed, even within a year, this is a consideration worth keeping in mind.
DAP guides will ideally be tailored to particular roles, so that users are presented only with relevant prompts as they interact with a system. Individuals can opt to turn off the guides once they understand what’s required and are using the software routinely. Where issues remain, and help continues to prove of value, built-in HEART analytics (tracking Happiness, Engagement, Adoption, Retention, and Task Success) offer a useful source of feedback about specific points of difficulty in a system (handy for refining the system, or for improving initial training).
Optimising DAP for compliance impact
The value of each DAP guide depends on the quality and relevance of its content, so this should be created and honed for each user group or role, and refreshed as required. A popular feature of all DAPs is that they can be used very effectively to make system-related announcements to users as they log in, e.g. about changes to the system, or to data input requirements (rather than hoping a blanket email will reach all of those affected).
The platforms are also coming into their own as AI is introduced to a whole range of operational software. In common with any new technology, AI needs to be used carefully and correctly to ensure compliance and elicit reliable results. DAPs are ideal as a mechanism for this, to provide essential, step-by-step, in-app guidance.
Budget-wise, DAPs can boost the value of traditional training, allowing more of this to be elevated to more of a strategic role around the purpose of a new system, for example. This creates scope for companies to allocate their budgets and materials expenditure more efficiently. It is for all of these reasons and more that 2025 is expected to be a pivotal year for DAP in a pharma GxP compliance context.
More than anything, this is about bringing a more intuitive experience to users that complex systems may lack (but which is necessary to ensure consistency and compliance). If automatic, timely intervention saves guesswork, or avoids a delay as assistance is sought, the payback is self-evident.
Finally, DAP support is likely to become increasingly predictive, anticipating what users are trying to do – e.g. “It looks like you’re entering new drug substance and product information, do you need help?”; further ensuring they do what’s required. Interventions like these will be invaluable in the modern pursuit of consistent data of the highest quality.
About the author
Sabine Gölden is eLearning & training lead at MAIN5, a European consulting firm delivering digitally-enabled change in Life Sciences. Gölden can be reached via email at sabine.goelden@main5.de.
References
[1] Digital Adoption Platform Market Size, Share, Industry Analysis, Trends, Growth, 2032, Zion Market Research: https://www.zionmarketresearch.com/report/digital-adoption-platform-market
[2] Value of a DAP, white paper, Whatfix: https://whatfix.com/resources/whitepapers/value-of-a-digital-adoption-platform/
