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

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"Because this is a pivotal trial, it is imperative that we work with an ePRO provider with knowledge of the respiratory and standardized questionnaires in our trial."

Narinder Shargill, Ph.D.
Vice President of Clinical Affairs
Asthmatx Inc.

Read more on what people are saying about PHT.

ePRO SitePad Tablets- Electronic Device for Clinical Trial Data

SitePad Tablet – Preferred by Clinicians for its Ease-of-Use

The PHT SitePad tablet continues to capture site-based questionnaires, patient reported data (PRO) and clinical trial survey data efficiently and easily. Clinicians prefer the touch-screen convenience. It is available with a 10” or 12” screen which is ample size to display each question and all available answers, to avoid scrolling bias.

The PHT SitePad tablet is used at a clinical site to electronically collect

  • Clinical Outcome Assessments (COAs)
  • Clinician Reported Outcomes (ClinRO)
  • Patient reported data from the subject (ePRO)
  • Site surveys
  • Questionnaires

Easy-to-use by Clinicians and Subjects

  • Available in a 10” or 12” screen
  • Use a fingertip or stylus to enter data
  • Lightweight and portable
  • View VAS and other large visual scales on a single screen
  • Transmit data via Ethernet or GPRS
  • Supports up to 500 subjects at a site

Attributable, Time-Stamped Data for Rapid Analysis

  • Restricted time response window
  • Provides branching logic and protocol-specific workflows
  • On-device calculations, dosing calculations and prescription capabilities
  • 21 CFR 312.62. compliant
  • Patented handwritten signatures and private access codes
  • Prevents data loss, destruction, tampering, unauthorized disclosure and or alteration
  • Real-time data available for analysis on PHT portal
  • Compliance data available on any smartphone

Increased Efficiencies for Sponsors and CROs

  • Support for over 97 languages, including multiple Asian and Indic character sets
  • On-device training devices provided
  • Enables seamless mid-study changes while SitePad tablets remain in the field
  • Can be used in combination with smartphone, Internet and hand held data collection
  • Includes online training modules in addition to IM instruction
  • 24/7/365 Support Center owned and managed by PHT
  • SitePad tablets are leased, to avoid capital investments and eliminate device obsolescence issues


Learn More about the SitePad Tablet

Is it fit for purpose? Which questionnaires have been implemented by PHT? Contact PHT for more detailed information.