FDA PRO Guidance and ePRO patient reported outcomes solutions with patient eDiaries

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"PHT knows how to deliver high-quality ePRO trials and we can trust that their system will work reliably throughout the entire study."

Al Stockalis
Senior Director, ISQA Department of Corporate Quality Assurance
Purdue Pharma L.P.

Read more on what people are saying about PHT.

What is ePRO?

Electronic patient-reported outcomes (ePRO) refer to the electronic capture of patient self-reported data. Most commonly implemented as eDiaries on convenient handheld devices, ePRO solutions offer sponsors higher quality data with accurate timestamps and real-time data access. ePRO digital diaries enable new types of eClinical research resulting in less variable and more reliable data for smaller trials and better scientific conclusions.

End-to-End ePRO

PHT's ePRO Product Suite is a complete turnkey solution, providing everything sponsors, sites and subjects need to collect and manage patient data:

  • Device hardware (LogPads and SitePads)
  • Global transmissions and SimpleSend telecommunication options
  • ISO certified quality management system
  • Scientific review and design consulting
  • ePRO Designer and custom programming
  • Trial Success Program implementation best practices
  • An experienced and persistent Project Management team
  • Documented application and system validation including User System Testing (UST)
  • Validated translations and product localization
  • Centrally hosted redundant study servers
  • Real-time data access and management via StudyWorks
  • User and site training
  • Expert ongoing Study Support
  • Global shipping, receiving and tracking logistics
  • On-demand data transfers
  • Study archiving
  • Complete system validation including regulatory compliance with 21 CFR Part 11 and the CSUCT guidance

All eSource, All the Time

ePRO is a type of eSource, which is source data captured initially as a permanent electronic record. With eSource data, sponsors no longer have to worry about incorrect transcriptions or falsified copies. eSource data helps shorten trial timelines and the time to diary database lock by eliminating the need for double-data entry, manual scoring, source document verification and most data queries. Further facilitating trial management is the easy integration of eSource data into other EDC and back-end CTMS systems.

Learn More about ePRO

What kind of data can I collect using ePRO? What types of trials are a good fit for ePRO? Contact PHT for answers to these questions or any others you may have.