Portfolio Management for PIL User Testing

The Client…

• a large generics company that needed to organise Patient Information Leaflet (PIL) readability testing for its entire UK portfolio of over 40 products
• was under significant time pressure with only 6 months to go before the UK deadline for marketed products
• had no previous experience of PIL User Testing
• needed specialist external resource with a proven track record for this specialist activity

…so what we did was…

• review the Client’s portfolio and define the optimum testing strategy which complied with current regulations while managing costs
• liaise with the MHRA to refine the strategy
• develop and manage complex programme timelines
• ramp up resources by doubling the size of our participant database and open new test centres to increase testing throughput
• recruit and train additional interviewers to maximise our testing potential while maintaining quality
• tested 18 ‘parent’ leaflets and bridged more than 40 ‘daughter’ leaflets in focus tests and delivered all reports within 6 months

…and the outcome was…

• every readability test was submitted to the MHRA within the deadline
• to date, agency questions have been minimal and quickly dealt with
• the Client asked Spectrum to undertake a similar exercise for their similar-sized Irish portfolio
• Spectrum utilised experience from the UK project to deliver significant Client benefit; project management efficiency, faster delivery and reduced costs for testing of the Irish portfolio

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