Toronto, Ontario (PRWEB) January 30, 2013
PRO data is recognized by most regulatory authorities including the FDA and EMA as important and acceptable endpoints in clinical studies. PRO have historically been recorded on paper diaries requiring subsequent transcription which can introduce human error, data queries and time delays. Its electronic format (ePRO) offers many inherent benefits including increased quality and reduced time to database hard lock. Due to legacy software issues and logistics, this tablet-based technology has not been available from other vendors. Inflamax has devoted considerable time and resources to develop its ePDAT™ system to improve user experience, accuracy and quality, while ensuring compliance with FDA and EMA requirements for validated ePRO data collection tools. ePDAT™ is fully CFR21 part 11 compliant.
“Although ideal for any type of PRO data collection, the ePDAT™ is the first ePRO system specifically designed to meet the needs of allergy and asthma clinical trials as well as Environmental Exposure Chamber (EEC) studies. Data can be collected in the EEC and at home with ease. Our validation studies have shown an enormous preference to using this system versus the traditional paper diaries. We are excited to have this technology available for our upcoming EEC and field hybrid studies. This is the first ePRO system that is capable of next-generation e-data acquisition including geo-positioning, Intelligent Follow-on™ questions and Smart Compliance™ measures built into the base software.” says Dr. Piyush Patel, CEO of Inflamax.
The validated ePDAT™ system provides a graphical user interface via a touch screen tablet computer designed to provide a vastly improved user experience. PRO data can be collected by a number of methods which include on-screen questionnaires, visual analog scales (VAS), response time, coordination tasks, high resolution image capture and evaluator interview
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