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

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"(The LogPad) is a great tool to capture time-sensitive data. In daily symptom diaries, recall bias is a real problem and it's difficult to assess actual compliance rates. The LogPad has worked out great - the patients have been very happy with it, and from our perspective it improves the accuracy of the data."

Nadia Hansel, MD, MPH
Instructor, Division of Pulmonary and Critical Care Medicine at Johns Hopkins University
Asthmatx AIR2 Trial

Read more on what people are saying about PHT.

Electronic LogPad System- Clinical Trial Data Management for Medical Patients

PHT LogPad –Trusted by Sponsors for Over Ten Years

As the voice of the patient becomes increasingly relevant in drug approvals, trial sponsors need new and better ways to collect and manage PRO data. PHT's LogPad System is the most trusted ePRO solution used in clinical trials around the world.

Make the Most of Every Patient

The PHT LogPad is a handheld device dedicated to collecting patient reported data (PRO) electronically. It has been successfully deployed in more than 400 global trials, which is testament to its ease-of-use, convenience and unheralded ability to collect attributable endpoint data for claim submissions.

PHT has standardized its LogPad System on Windows Operating System and the widely accepted Palm platform. There are four unique LogPad models to consider, each with its own distinct advantages of ensuring protocol compliance. The LogPad is mobile, and includes a long battery life. Each comes with a battery charge and unique transmission device. Each question and full set of answers are displayed on the screen, to avoid scrolling bias. Subjects are reminded to complete their questionnaires with alarms and alerts generated by the LogPad, and answer questions with a stylus.

Collect Electronic Patient Reported Outcomes (ePROs)

The PHT LogPad is used by the subject at home, work or in transit to electronically collect

  • Patient reported data from the subject (ePRO)
  • Surveys
  • Questionnaires

Easy-to-use by Subjects

  • Use a stylus to enter data
  • Lightweight and portable
  • View VAS and other large visual scales on a single screen
  • Transmit data via Ethernet or GPRS

Attributable, Time-Stamped Data for Rapid Analysis

  • Restricted time response window
  • Front-end edit checks and range rules
  • Provides branching logic and protocol-specific workflows
  • On device calculations for real-time symptom scoring, alerts and calculations as subjects enter data
  • Patented handwritten signatures and private access codes
  • Prevents data loss, destruction, tampering, unauthorized disclosure and or alteration
  • 21 CFR 312.62. compliant
  • 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 LogPads remain in the field
  • Can be used in combination with smartphone, Internet and tablet data collection
  • Online training modules in addition to IM instruction provided
  • 24/7/365 Support Center owned and managed by PHT
  • LogPads are leased, to avoid capital investments and eliminate device obsolescence issues

LogPad Custom Design Ensures Protocol Compliance

  • Diary alarm
  • Automatic Data Transmission
  • Flexible designs for patient populations of all ages
  • Reliable analog and wireless worldwide transmissions
  • Real-time reporting through StudyWorks
  • Wireless integration with glucometers, PEF meters, and other measurement devices via eSense™

LogPad Fosters Improved Clinical Care during the Trial
By sending data every day, subjects around the world consistently say that using the LogPad improves their level of care, because their site is actively listening to them (as opposed to keeping paper diaries which can go un-reviewed for weeks). Similarly, study coordinators appreciate the ability to see how patients are doing on a daily basis.

Learn More about the LogPad

Is it fit for purpose? Which questionnaires have been implemented by PHT? Contact PHT for answers to these questions or any others you may have.