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Urology trial goes e-PRO
A large--but unnamed--drugmaker conducting a Phase II trial for a urology treatment will use electronic diaries to collect patient-reported outcome data. The 750-subject trial spans 22 countries on three continents and requires use of 34 languages, according to an announcement.
The sponsor selected the etrials eDiary 5.0 platform from Merge Healthcare. The manufacturer's eDiary Inventory Module, for tracking the shipping and supply of study data-capture devices, will also be used.
The eDiary 5.0 software, based on the Windows Mobile operating system, runs a ruggedized handheld device, the manufacturer says. Patients enter outcomes data using the device and then upload the data to a centralized electronic repository, where it is accessible to trial managers in real time.
- here's the announcement
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