Why aren’t more life sciences companies automating PV data capture?
SummaryWhy are Safety & Pharmacovigilance departments lagging in their application of smart technology, when the pressures on pharmaceutical organisations to capture, sift and process real-world adverse event data are vast, asks John Price, a life sciences regulatory and safety consultant and advisor to Arriello.
- Author Company: Price PharmaSolutions LLC
- Author Name: John Price
Compared with other functions across the pharmaceutical product lifecycle, Safety and Pharmacovigilance (PV) teams are the least likely to employ smart technology to help lighten the load. This is surprising given that life sciences companies today spend a disproportionate amount of their PV budget simply amassing reports of suspected drug reactions - which are often of poor quality. So what’s stopping them exploiting proven technology to lighten the load?
Building the business case
In pre-marketing authorisation activities such as clinical trials, technology is seen as a means of accelerating products’ speed to market, expanding the target opportunity, and bringing in new revenue.
PV, by contrast, is seen as a ‘cost centre’. This is lamentable, given the scope for process transformation that today’s technology enables. Proven solutions exist now which could transform the efficiency, effectiveness and regulatory adherence of PV processes, without placing data at any risk of being compromised in any way.
Meanwhile global players often prefer to build their own customised solutions, keeping these shrouded in secrecy as though they might offer some kind of strategic advantage. This is puzzling. While Big Pharma clearly has the resources to develop its own solutions for adverse event (AE) case intake and processing, companies would surely be better off – financially and time wise- using ready-to-go tools which have been tried and tested many times over.
The quantity/quality trade-off
AE case reporting is labour intensive and requires specialist skills, which are in short supply. It is critical, then, that companies apply that expertise economically and where it is needed most: to identifying and evaluating incoming signals, and addressing safety issues. Even if organisations do see PV as a cost centre, it is one that warrants investment as a means of providing services more cost-efficiently – without compromising PV quality or integrity.
In the right hands, advanced technology can reduce errors to drive up PV accuracy while simultaneously driving down operational costs over time. Efficiency gains of between 60-70 per cent have been predicted where companies are targeting largely manual and resource-intensive processes with intelligent automation, and higher efficiencies are perfectly possible; the kinds of innovation which don’t require a wholesale overhaul of firms’ existing PV systems. This includes case intake solutions which frontline professionals can use on the go, to capture AE details for straight-through processing.
As a rule-based activity, AE case processing lends itself perfectly to automation. A report made by a healthcare provider, patient or drug company representative via a smart phone app, for instance, could be triaged, databased and routed automatically to company staff or regulators, with minimal human intervention. Benefits include greater ‘right-first-time’ capture of comprehensive, high-quality case information at source - reducing the need for case follow-up. The convenience of such a system would save time for all involved, and enable more effective PV.
Seizing the day
For now, applications that automate discrete PV activities, available from specialist PV IT providers, offer opportunities for incremental efficiencies to smaller companies with modest budgets who could otherwise be left behind in the imminent PV automation revolution.
As long as large pharma brands continue to develop their own customised PV solutions, mid-sized and smaller firms have a chance to peruse the market for off-the-shelf solutions or managed services which employ such aids to improve the quality and value of PV delivery. This window of opportunity is likely to be finite, though. Before long, demand may exceed the available capacity of technology service providers, leaving smaller players without the help they badly need.
About the author
John Price, owner and MD of John Price PharmaSolutions LLC, is a life sciences regulatory and safety veteran and consultant, and an advisor to PV managed service provider Arriello. www.arriello.com