Product/Service

NetPRO: Web-based ePRO Collection

Source: PHT Corporation

PHT Corporation

PHT NetPRO collects patient and clinician data for clinical trials and post-marketing studies via the Internet. Like all other PHT modalities, PHT NetPRO data is immediately viewable by sites and sponsors via the PHT StudyWorks™ portal.

 

PHT NetPRO collects patient and clinician data for clinical trials and post-marketing studies via the Internet. Like all other PHT modalities, PHT NetPRO data is immediately viewable by sites and sponsors via the PHT StudyWorks™ portal.

PHT NetPRO is an economical method for collecting patient reported outcome data or post-marketing safety data from large populations, and may be used to submit PRO data to support a labeling claim.

NetPRO is most practical for trials with

  • Available patient populations in North America and Western Europe
  • Regularly scheduled or infrequent data collection time periods, and
  • Relatively simple diaries or questionnaires.

 

Advantages of Using PHT NetPRO for ePRO data collection

  • Use of patient's own technology improves patient enrollment
  • Trial costs are reduced by using patient's Internet technology
  • Larger screen size eliminates text abbreviations
  • Layout similar to paper reduces validation of electronic questionnaires
  • Progress bars improve patient compliance
  • Restricted time response windows verify data entry, eliminate recall bias
  • Accurate timestamps and private logins ensure data attribution
  • Patients receive SMS and email alert reminders

 

NetPRO meets the ePRO System Requirements set forth in the FDA PRO Guidance and Draft eSource Guidance which encourage sponsors to collect data directly from patients using electronic systems.

The PHT ePRO System is 21 CFR Part 11 compliant and meets the requirements of regulatory agencies including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union (EU), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Pharmaceuticals and Medical Devices Agency in Japan (PMDA).