News & Views
Quality key in PV finds Ariello survey
Interest in pharmacovigilance (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, according to the latest survey by regulatory affairs, pharmacovigilance and auditing solutions and services expert, Arriello (www.arriello.com).
Conducted on both sides of the Atlantic, the survey reveals that quality has overtaken price as a priority in plans for automating adverse event (AE) reporting. Quality is now the primary focus with over 70% of respondents saying that was the main driver for investing in PV automation, and improved data quality is the chief objective of automation initiatives, cited by 35% of respondents – rising to 40% among those in Drug Safety roles.
In Product Safety teams the survey found that the need to improve compliance was cited by 44% of respondents. As 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.”
However, as Dr. John Price, life sciences regulatory and safety consultant and a member of Arriello’s Pharmacovigilance advisory board explains, “After ten years of outsourcing, and then offshoring their activities, Pharma is finding that the cost savings achieved have been at the expense of quality. As a result, some are seeking to rebuild internal PV capabilities – despite the higher cost, not to mention a talent shortage. An alternative solution is to harness technology, specifically AI and process automation solutions.”
According to the survey, 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).
However, when it came to AE reporting, the survey says the figures – as last year – are perplexing around AE reporting. This remains a high-pressure activity for pharma organizations, 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% of all respondents, rising to 48% 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 organizations, 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. As we ventured last year, this suggests that companies are still not realising the fuller potential of automation,” comments Price.
The survey be found at: