Electronic Patient-Reported Outcomes

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Business & Decision Life Sciences is able to adapt any paper PRO measure into an electronic interface that can be applied to different devices such as tablets, computers, and phones.

We have the expertise to develop a web interface or IVRS of the PRO measure that is compliant with regulatory documents and include the following characteristics:

  • Audit trail.
  • Secure system with secure unique user login and password.
  • User friendly web navigation.
  • Validation checks: Ensures data fields are complete/questions are answered correctly (checks data upon entry for format, range, type, and allowable values).
  • Real-time data downloads and access to data: sites and sponsors can access patient ePRO data and diary compliance metrics in real time.
  • Reports with compliance details.
  • Localized Date/time stamping of patient responses.
  • Able to support multiple languages.
  • Allows patient to Exit, Save, & Resume during long visits.
  • Auto-resend data until data transmission is successful.
  • Human readable copies.

To guarantee data integrity and quality, Business & Decision Life Sciences will validate and document the process used to develop, test (user acceptance testing), support, maintain, and decommissionate the ePRO system.

In addition to our expertise in the development of ePRO tools, we can provide you support to select the rigth PRO measure to include in your clinical trial, implement it in your study, analyse your PRO data, and develop high quality reports and articles.

 

Benefits

Improve data quality

  • Allow to enter only formatted responses.

  • Prevent to skip mandatory information.

  • Limit missing/inaccurate/ unreadible data.

  • Data are stored directly to a central database; reduce data entry error.

Improve compliance with protocol

  • Remind automatically to complete (e.g., alert).

  • Limit delayed entries.

  • Possibility to monitor compliance (e.g.record date and time for each entry automatically).

IVRS : no hardware required for the respondent other than a telephone

  • Little if any respondent training is necessary.

  • Reduce the literacy skill requirements of study participants.

  • IVR systems allow for respondents to call in or for the system to call respondents.

Web-based ePRO : economical method for collecting PRO data from large populations 

  • Ideal solution to collact data in real-world settings.

  • Easy availability at the site and patient's location.

  • Ease of use.

  • Highly compliant data without any investment in any hardware.

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