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Pi2 Solutions Presents on Pharmacovigilance Literature Screening at Major European Risk Management Meeting
Date:11/11/2013

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.

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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 D
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SOURCE Pi2 Solutions Ltd
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