Electronic Patient Reported Outcomes ePRO’s

EDC electronic patient diary such as ePRO Electronic Patient Reported Outcomes (ePROs) commonly known as Patient Diaries, and electronic Clinical Outcome Assessment (eCOA) improve data validity through the capture of dates and timestamps, while real time data input validation creates an audit trail revealing “true” diary compliance. The use of electronic diaries is supported by scientific research that shows memory recall of an event is often unreliable and laden with inaccuracies, further supporting the use of ePRO and eCOA versus traditional paper diaries or interviewing techniques.

Fundamentals of the HealthDiary ePRO System

The HealthDiary™ ePRO system uses specially designed Tablet or Mobile phone devices for instant data capture and transfer to a centralized data centre from anywhere in the world where cellular coverage is available, or off-line for “off-the-grid” data collection.

  • Compliance cannot be faked and can be tracked and verified
  • Controls timing and validity of subject data entry
  • Increases clinical trial data analysis efficiency
  • Allows for complex assessment and real-time algorithmic data analysis
  • Easy to use and deploy
  • Multi-language and Time Zone capable
  • Secure and encrypted communication

The HealthDiary™ ePRO solution has been tested and deployed in 26 countries, multiple languages and time zones.

 Compliance Rates

Patients regularly achieve high compliance rates of more than 95% and are comforted my the notion that someone is watching over them. Our highest compliance is 99.9% of 28,514 possible daily diaries in a Canadian COPD trial (Johnston et al., CHEST, 2013)

Data Quality

Structured data input fields ensure real-time data validation where data must be entered consistently, completely and within the specified data ranges set forth in the study, while symptoms and readings are captured and entered by study subjects

Subject Involvement

Subjects are automatically notified when diaries are available and are reminded when to complete as well as HOW and WHEN to contact an Investigator – should symptoms change

Real Time Access to Patient Data

Researchers can access real time data to assess compliance and automated algorithms can detect symptom changes to proactively detect clinically significant events. i.e. COPD Exacerbations

SECURITY

  • Secure – SSL encrypted communication protocol & CFR Part 11 Compliant
  • No data stored on the device itself – easy ERB approval
  • Controlled by central servers and management software

The HealthDiary™ HealthPad is a handheld device and a software solution designed to capture electronic Patient Reported Outcomes (ePRO’s) commonly known as Patient Diaries, and electronic Clinical Outcome Assessment (eCOA). HealthPads are easily expandable and customizable through software and add-ons to capture a variety of clinical trial data. HealthPads can be configured for real time data transfer using SIM cards and Cellular networks from anywhere in the world where cellular coverage is available, and Off Line storage for “off-the-grid” data capture.