The growing sophistication of pharma Clinical, Regulatory, Quality, and Pharmacovigilance process digitalisation, including the shift to data-based reporting and decision-making, is presenting a challenge to overstretched teams trying to navigate multiple different user experiences.
MAIN5
Digital adoption platforms (a simple overlay to web/cloud-based systems) offer a practical solution, guiding users of each application, step by step, in correct, compliant data input. MAIN5’s Sabine Gölden assesses their potential.
Global estimates suggest that a typical international organisation today uses over 500 different software applications, with some individual departments possessing more than 80. In life sciences, an industry subject to strict regulations and standards, this can add up to a lot of prescribed actions and required data and information formats to navigate, and processes to remember.
In pharma, already overstretched departmental teams risk being paralysed by the widening array of digital processes and IT systems, and their growing complexity as regulatory requirements evolve and system functionality is updated. For employees to feel confident, and fully exploit the potential of powerful new systems, they must first know how to use them correctly.
Traditionally, comfortable and compliant use of technology would be ensured via good training, cemented by routine use of the required systems. Yet in a GxP context, where mandated practise is continuously evolving, neither can be taken for granted. The same applies to seamless compliance, no matter how intuitive modern technology has become. There will be some systems that, by their nature, employees use only intermittently, compromising their ability to recall the specifics of initial training.
These are among the very practical reasons that digital adoption platforms (DAPs) are now gaining traction in a pharma GxP 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, according to the main platform vendors.
Already proven in central business functions
DAPs already have a robust track record 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 20321). 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.
Although new-system training is a formal expectation in a GxP context, that doesn’t guarantee compliant use, inviting risk - particularly as key processes and decision-making become increasingly data driven. The shift 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. That might include bringing across the right data, in the correct format, from legacy systems now entering retirement.
Certainly, data integrity, data quality and data governance are big themes in life sciences today and, by extension, the scope to call up, exchange, and re-use data as the basis for important insights and critical reports. 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 have a big impact though, yielding at least a 20% improvement in data accuracy2.
No security worries, yet plenty of scope for user data capture
Although the introduction of any new software facility must be treated carefully in a GxP context, 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).
Easily adaptable, and a reliable vehicle for new system announcements
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 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.
DAP support could become more predictive over time too, 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?”. The possibilities are considerable, and wide-ranging.