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ePRO Excellence

Clinical trial sponsors can reap many rewards from collecting patient reported outcomes electronically in multinational clinical trials. Advantages include significant improvements in clinic and subject compliance, data quality, data access and monitoring, as well as reduced staff and subject burden. Yet, as many know, ePRO can also present challenges. By understanding some of the important ePRO best practices, however, sponsors can overcome or bypass the major challenges, and then can more easily realise the promises and benefits that ePRO can offer.

BRIEF SUMMARY OF THE CHALLENGES

One of the major challenges a sponsor faces when using ePRO in multinational trials is ensuring the quality and reliability of the ePRO systems and data files. After all, even small problems with the systems or data can sometimes damage credibility, which can lead to decreased system usage, increased enrolment, queries, and other trial costs, and at worst, the discrediting of all the ePRO data.


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Joy Hebert is a co-founder and Chief Operating Officer of .assisTek (formerly Assist Technologies), the global leader in ePROs on touch-screen tablets. Joy has worked in healthcare informatics for 30 years. For the last 15 years she has managed the development and implementation of ePRO systems in clinical studies worldwide.
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