According to new research, quality has exceeded cost as a priority in plans to automate adverse event reporting. John Price reveals the drivers and obstacles to change.

According to new research, quality has exceeded cost as a priority in plans to automate adverse event reporting. John Price reveals the drivers and obstacles to change.

Although the COVID-19 pandemic has blocked progress in transforming digital processes, the ambitions of many life science companies to apply smart solutions to increasing pharmacovigilance (PV) workloads remain at the heart of the program. investment. These are the findings of Arriello’s second annual transatlantic survey of 200 professionals in leadership positions in PV, Drug Safety and Product Safety, examining industry intentions for PV automation.

This year, quality has overtaken cost to become the main criterion for automating PV workloads. Yet fear of human jobs, along with validation issues, persist as barriers to automation.

The context of the research is the change in the treatment of PV by companies. About a decade ago, as the Adverse Event Reporting (AE) workload began to increase, pharmaceutical companies sought to reduce the cost of their operations, first by outsourcing , then by relocating their activities. In recent years, Pharma has started to realize that all the associated cost savings come at the expense of quality. Today, some are looking to rebuild in-house PV capacities, despite higher costs and a talent shortage, by harnessing smart technology. But how far have companies gone?

Automation intentions are strong

Unsurprisingly, the pandemic has dominated decision-making over the past year, resulting in setbacks in automation initiatives. The proportion of respondents who said they implemented PV automation solutions in 2021 was about the same as in 2020, despite around 40% of respondents last year expecting to introduce automation in the next year. year to come. Intentions remain strong, however. Only two percent saw automation projects completely downsized.

Whether categorized as robotic process automation (RPA), stand-alone PV automation, or PV automation as part of something bigger, up to two-thirds of companies said they had solutions “already in place” or were ” likely ”to do so within the next 12 months.

Yet it soon became clear that respondents generally did not refer to the application of smart solutions to end-to-end case handling (case collection, database work, triage, reporting). On the contrary, many seem to be taking advantage of IT to support isolated elements of case processing, such as automatic report scheduling for submission and automatic narratives.

This is a shame, given the wider possibilities for automating processes now – for example to simplify the work of rapporteurs (healthcare professionals, patients), allowing them to report directly into the PV database, by avoiding the effort of data entry. This is conceptually similar to Electronic Data Entry (EDC) commonly used in clinical trials.

Our own observations suggest that many organizations employ EDC in clinical development, in electronic notification of security cases to agencies, in generating automatic narratives, in tabs and schedule listings for aggregate reports, etc. This feature is often included in platforms provided by security vendors and tends to add little value to PV teams.

When the 2021 survey asked where companies plan to invest in intelligent (AI-enabled) or robotic (RPA) process automation, clinical documentation management was the area most likely to have already been automated, tracking information management on product quality compliance and medical information management. , then compilation of standard documents (forms, PSMF, aggregated reports, etc.). For investments over the next 12 months, document analysis and automatic storytelling dominated the plans: beyond that, smarter management of regulatory information and automated document compilation.

Yet the numbers are still puzzling. AE reporting remains a high pressure activity for pharmaceutical organizations and in this year’s findings 42% of all respondents (up to 48% in the UK alone) said they have reporting solutions in place. Automated AEs already operational.

Yet our experience suggests that automating end-to-end case processing is relatively rare in the industry. The high rates of EA automation reported in the current survey are more likely to refer to very limited application, then – related to specific elements of the overall EA processing system – rather than the implementation of a complete new platform to ease manual data management.

Quality takes precedence over speed

To find out more, research led to the Conductors for investing in PV automation – finding that quality (cited by 71%) exceeded cost (cited by 63%) by a certain margin, and even exceeded delivery speed (cited by 67%).

From a quality perspective, improving data quality is the primary goal, cited by 35 percent of those surveyed, reaching 40 percent among those in drug safety positions. For speed-related improvements, expedited processing was the top benefit sought, cited by 34% – rising to 38% for drug safety teams, who also prioritized faster reports.

In terms of the cost reduction benefits of automation, product safety teams were more likely to seek lower infrastructure costs and less likely to target workforce replacement.

Further investigation, linked to existing capabilities, found that automation solutions clearly hold perceived value in a PV context, but companies need leeway to scale up and for the benefits to be more visible. and easier to access. As one respondent noted in an open response: “PV automation facilitates quality assurance. It is simply a matter of overcoming validation requirements and facilitating 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 impressive results.

Familiarity, ease of use and cost – the barriers to automation

In last year’s PV automation survey, the top three perceived barriers to PV automation were IT related. This year, although the familiar challenge of validating the system remained a top concern, cited by more than four in 10 respondents (as in 2020), familiarity, ease of use and cost were the next biggest hurdles. important to the adoption of new automation opportunities.

Fear of human replacement was a particular problem for PV teams (cited by 42 percent of this cohort, compared to 22 percent 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 for the retention of talent who is currently significantly overloaded.

A perceived lack of suitable solutions was cited as a barrier to adoption by 43 percent of survey participants in the UK, compared to 27 percent in the US. This further reinforces the conclusion drawn last year that there are different perceptions of what constitutes ‘automation’ – that is to say that the technology and service provider industry needs to redouble its efforts to educate the market about emerging options.

This system validation still presents as such a high barrier to innovation / process improvement is disappointing. Photovoltaic professionals know how to validate a system and have the resources to monitor systems and confirm that they are doing what they are supposed to do, with the quality and consistency required. This apparent barrier certainly deserves further exploration to ensure that it does not prevent the adoption of more innovative IT solutions that could greatly benefit PV teams.

One of the industry’s next priorities must be to find ways to work around the system validation issues that continue to prevent businesses from more easily capitalizing on rapidly evolving next-generation automation capabilities.

PV and safety functions want to do more

Businesses now clearly prioritize processing quality and speed over cost when exploring new automation options. There are encouraging signs that PV and Security want to do more to advance the automation of their operations, and improve data quality and report processing / delivery speed in particular. Accessible and user-friendly AE automation solutions, delivering productivity benefits from day one, support this goal.

Dr John Price is an executive physician with over 25 years of experience in regulatory affairs and pharmacovigilance worldwide. He is a consultant in the life sciences industry and partner of Arriello, a provider of risk management and compliance services.

About the research

The Arriello 2021 survey was conducted by Censuswide in July / August. As in 2020, it surveyed 200 senior professionals in PV, drug safety and product safety functions in life science companies of all sizes, split evenly between the UK and the US. The full report can be downloaded here.

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