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Pi2 Solutions Presents on Pharmacovigilance Literature Screening at Major European Risk Management Meeting

LONDON, November 11, 2013 /PRNewswire/ --

Pi2 Solutions was invited to present its findings from consulting on literature screening workflow among top pharma companies at the 9th Annual Pharmacovigilance, Drug Safety and Risk Management, held this year in London.


Reporting experiences found when analysing the workflows of several top pharma companies, Pi2 noted the extremely disparate systems and methodologies encountered among these companies as they strive to meet regulatory obligations to review literature for adverse events.

Most importantly, and well recognised by the organisations themselves, was the amount of time spent administrating and processing published references, as distinct from the time spent on the core tasks of the evaluation of a paper for adverse events, making decisions on  the findings and sending these speedily into the most appropriate internal stream for action.

Between two and ten minutes spent on administrative tasks per item screened were cited as being unnecessary - potential efficiency savings. This equated in some instances to the time of several FTEs when considering that companies are required to screen up to several hundred thousands of items per year.

When screening for ICSRs it was revealed that among Pi2 Drug Safety Triager™ clients, an average of only 4% of references were found to have case criteria.  For aggregate reports and signals, the references with criteria were 5.5% and 0.1% respectively. "This underlies the need for a streamlined reference review process and for expensive internal resources to be deployed effectively to screen out of the vast majority of papers which are of no safety relevance", noted Mark Drinkwater of Pi2.

The analysis was conducted as part of rolling out the Drug Safety Triager™, Pi2's platform to streamline reference screening, which has enjoyed a rapid uptake in the industry.

Other trends noted included an increasing tendency towards outsourcing - also highlighted by a number of market research findings last year. A natural evolution for companies familiar with the Drug Safety Triager has been Pi2's outsource model - where the Pi2 team has been engaged in the US and Europe to conduct the screening of literature for its clients.

"While uptake of this initiative has been most notable among the larger pharma companies, it is clear that smaller companies could benefit as much, if not more, from a more streamlined, cost-effective and efficient approach to drug safety screening", remarked Nigel Johnson, one of the presenters of the conference session.

About Pi2 Drug Safety Triager™

The Pi2 Drug Safety Triager™ allows the rapid screening of incoming literature for ICSRs, PSURs, Signals and for related purposes where speed, efficiency, accuracy and compliance are of importance. The Pi2 Drug Safety Triager™ automatically imports references from a client's existing biomedical alerts and surfaces these, together with full articles, for rapid review, annotation and downstream processing to the client's drug safety database. The intuitive interface is easy to use, reduces errors and eliminates many unnecessary steps often associated with literature review. Review is undertaken by the client's in-house team or outsourced to Pi2's team of experience screeners.

With seamless connectivity to an organisation's existing online host's alerts or web-service and preferred document delivery vendor or virtual library, the Pi2 Drug Safety Triager™ is easily and rapidly implemented with minimum disruption or time-consuming client set-up. Like other Pi2 literature management applications, the Drug Safety Triager™ is hosted and maintained by Pi2, lifting the burden of ownership from the shoulders of departmental managers and supporting IT teams.

About Pi2 Solutions Ltd

Pi2 Solutions Ltd is a privately owned London-based company specialising in Product Literature Database (PLD) systems for the biopharmaceutical industry and innovative "Workflow Applications" for key user groups in functions such as Medical Affairs, Marketing, Drug Safety and Publications Planning.

Established in 2002, Pi2 has an enviable portfolio of global biopharmaceutical clients, from the very largest pharma companies  - 50% of top pharma use Pi2 - to small emerging biotechs. The strategic aim of Pi2 is to continue to develop novel solutions for solving the workflow challenges of users of drug-related literature in knowledge centres and in business critical roles who rely heavily on its efficient handling.

For further information contact either of the founding directors:


SOURCE Pi2 Solutions Ltd
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