COVID-19 may have delayed deployment, but interest in PV automation remains strong – and would be higher still if companies could overcome the perception of poor solution choice, validation challenges, and the learning curve linked to adopting new processes
Dublin, Ireland- Arriello, a provider of regulatory affairs, pharmacovigilance and auditing solutions and services for small to mid-sized biotech and pharma firms, has seen quality overtake price as a priority in plans for automating adverse event (AE) reporting, in its latest substantial pharmacovigilance automation survey conducted on both sides of the Atlantic.
The study also identifies fear for human jobs, along with validation issues, as a barrier to adoption – even though intelligent, digital case reporting offers to alleviate huge bottlenecks, drive up AE reporting reliability, and give valuable time back to busy professionals.
This is the second time Arriello has commissioned the transatlantic study. Conducted independently by Censuswide, the poll of 200 respondents – in senior roles spanning PV, Drug Safety and Product Safety departments – revealed that although the COVID-19 pandemic had delayed progress, plans to apply smart solutions to steep PV workloads had kept automation plans central to the agenda for investment.
Latest automation progress: misconceptions about PV-related potential
Overall, clinical documentation management was the area most likely to have been automated already, followed by product quality compliance information handling and medical information management, then standard document compilation (forms, PSMF, aggregate reports, etc). For planned investment over the next 12 months, literature screening and auto-narrative generation were the most popular areas of focus, cited by more than a fifth of respondents across the board.
Beyond that timeframe, smarter regulatory intelligence management and automated document compilation were the main areas under evaluation.
However, the figures – as last year – are perplexing around AE reporting. This remains a high-pressure activity for pharma organisations, because of the high volumes of incoming content, the diversity of capture points and formats, and the very tight timelines for reporting serious real-world safety events. In this year’s poll, as many as 42 per cent of all respondents, rising to 48 per cent in the UK alone, claimed to have automated AE reporting solutions already in operation.
“This jars with our experience, which tells us that the solutions currently in play at most organisations, or their outsourced service partners, are not true timesaving or quality-enhancing tools. Rather they are software systems into which professionals manually input their findings,” commented Dr. John Price, life sciences regulatory and safety consultant and a member of Arriello’s Pharmacovigilance advisory board.
“As we ventured last year, this suggests that companies are still not realising the fuller potential of automation.”
Quality now the primary focus
To delve deeper, this year’s survey asked about companies’ drivers for investing in PV automation. Across the research base these emerged as quality (cited by 71 per cent) and speed (mentioned by 67 per cent). Quality was deemed even more of an issue for those with a PV-specific remit, suggesting this is an area they are trying hardest to improve.
Quality-wise, improved data quality is the chief objective of automation initiatives, cited by 35 per cent of respondents – rising to 40 per cent among those in Drug Safety roles. For Product Safety teams, by far the bigger preoccupation is improved compliance – cited by 44 per cent of this cohort as the main goal of quality improvements, compared to an average of 34 per cent across all respondents. Operational improvements were also a priority, though less so in Product Safety.
A series of open responses proved illuminating too, in relation both to the quest for improved PV quality, and the perceived barriers to technology adoption. One respondent noted: “PV automation makes quality assurance easy. It’s just a matter of overcoming validation requirements and providing ease of access. Usability issues and fear of the unknown are what hold people back, which is a shame given that integrating functional events through PV gives awesome results.”