New research, involving 200 professionals in senior roles spanning pharmacovigilance (PV), Drug Safety and Product Safety departments, has found that quality has overtaken cost as a priority in plans for automating adverse event (AE) reporting. John Price, life sciences industry consultant and partner of Arriello, which commissioned this latest research, reports on the findings.
Although the Covid-19 pandemic has stalled progress with digital process transformation, many life sciences companies’ ambitions to apply smart solutions to rising pharmacovigilance workloads remain central to the investment agenda. These are the findings of Arriello’s second annual transatlantic survey into the industry’s PV automation intentions.
In 2021, quality overtook cost to become the primary criterion for automating PV workloads. Yet fear for human jobs, along with validation issues, persist as barriers to automation.
The context for the research is the shift in companies’ treatment of PV. A decade or so ago, as AE reporting workloads began to soar, companies across the pharmaceutical industry sought to reduce the cost of their operations – first by outsourcing and then by offshoring their activities. In more recent years, Pharma has begun to realise that any associated cost savings have come at the expense of quality. Now some are seeking to rebuild internal PV capabilities, despite higher costs and a talent shortage, by harnessing smart technology. But how far have companies come?
Pandemic setback to automation
Unsurprisingly the pandemic has dominated decision-making over the last year which has been reflected in setbacks to automation initiatives. The proportion of respondents claiming to have PV automation solutions in place in 2021 was much the same as in 2020, despite around 40 % of last year’s respondents expecting to introduce automation within the coming year. Intentions remain strong, however. Only two % saw automation projects curtailed completely.
Whether categorised as robotic process automation (RPA), standalone PV automation, or PV automation as part of something bigger, up to two-thirds of companies claimed to have solutions “already in place” or were “likely” to do so in the next 12 months.
Yet it soon became clear that respondents were not typically referring to the application of smart solutions to end-to-end case processing (case collection, database work, triage, reporting). Rather, many seem to be leveraging IT to support isolated elements of case processing, such as auto-scheduling reports for submission and auto-narratives. This is a shame, given the broader process automation opportunities now .
Automation of end-to-end case processing is rare
AE reporting remains a high-pressure activity for pharma organisations and, in this year’s findings, 42% of all respondents (rising to 48% in the UK alone), claimed to have automated AE reporting solutions already in operation.
Yet our experience suggests that automation of end-to-end case processing is relatively rare in the industry. The high AE automation rates reported in the current survey are more likely to refer to very limited application, then – linked to specific elements of the overall AE processing system – rather than implementation of a novel, comprehensive platform to alleviate manual data management.
To find out more, the research pushed for the drivers or investing in PV automation – finding that quality (cited by 71%) outranked cost (cited by 63%) by some margin, and was even ahead of speed of delivery speed (mentioned by 67%).
Quality-wise, improved data quality is the chief objective, cited by 35% of respondents – rising to 40% among those in Drug Safety roles. For speed-related improvements, accelerated processing was the main benefit sought, cited by 34% – rising to 38% for Drug Safety teams, who also prioritised prompter reporting.
IT no longer key barrier to automation
In last year’s PV automation survey, the three top perceived barriers to PV automation were IT-related. This year, although the familiar challenge of system validation remained a key concern, cited by more than four in 10 respondents (as in 2020), familiarity, ease of use and cost were the next most significant barriers to embracing new automation opportunities.
Fear of human replacement was a particular issue for PV teams (cited by 42% of this cohort, in contrast to 22% of those working in Product Safety). This suggests a misconception that job losses are inevitable when an automated solution is implemented, when in reality automation paves the way to retain talent which is currently considerably over-stretched.
A perceived lack of suitable solutions was cited as a barrier to adoption by 43% of UK survey participants, compared to 27% in the US. This further supports the conclusion reached last year, that there are differing perceptions of what constitutes ‘automation’ – ie. that the technology and service provider industry must work harder to educate the market on emerging options.
That system validation still presents as such a high barrier to process innovation/improvement is disappointing. This apparent barrier warrants further exploration, certainly, with a view to ensuring that it doesn’t go on to prevent the take-up of more innovative IT solutions that could benefit PV teams enormously.
Prioritising quality and speed over costs
It is clear that life sciences companies are prioritising quality and processing speed when exploring new automation options for PV. As companies focus on harnessing capabilities closer to home, they are increasingly looking to tap into accessible and user-friendly automation solutions that will drive more effective AE reporting.
About the research
The 2021 Arriello survey was conducted by Censuswide in July/August. As in 2020, it polled 200 senior professionals in PV, Drug Safety and Product Safety functions across life sciences companies of all sizes, split evenly between the UK and US.
About the author
Dr John Price is an executive physician with 25+ years of experience working across regulatory affairs and pharmacovigilance worldwide. He has held senior roles at the UK MHRA, as well as Pfizer, J&J, Alexion Pharmaceuticals, and worked in academia. John is an advisor to Arriello, a provider of risk management and compliance services to the life sciences sector – including market consultancy, global regulatory affairs strategy and implementation, complete PV solutions, clinical drug safety, and quality and compliance auditing systems.