ePRO Solution – Electronic Participant Reported Outcomes

Patientricity: Putting the patient at the center of the trial

Nearly every person today is walking around with a connected device in their pocket and, in some cases, on their wrist as well. Electronic participant reported outcome (ePRO) measures in clinical trials are a participant-centered approach to data collection utilizing native apps and wearable technology.

An ePRO Solution that is 21 CFR Part 11 Compliant

Clinical Studio has made it incredibly simple to automate participant reported outcomes measures through customizable notifications and by making 21 CFR Part 11 compliant data entry available to the participants themselves. Measuring participant outcomes has never been easier. Collect surveys at any interval or implement eDiaries into your clinical trial. Allow study participants to use their wearable device to send activity data directly to a clinical trial database. These latest innovations are not only making research trials more effective, but are helping to lower the cost of data collection and, ultimately, the creation of electronic clinical outcome assessments (eCOA) in clinical trials.

Electronic Participant Reported Outcome Measurement

At Crucial Data Solutions, we believe ePRO measurement features are some of the most important functionality a clinical trial can provide. These features make the clinical trial process easier for participants and researchers. That’s why the ePRO solution is available in two ways:

  • As a fully integrated part of studies running on the Clinical Studio and TrialKit EDC platform
  • As a stand-alone tool for studies being conducted outside of Clinical Studio and TrialKit

Here are a few ways a clinical trial can be enhanced with the ePRO system:

  • In addition to the standard data collection of simple multiple choice or open ended responses, participants can snap photos or videos directly into a survey
  • Participant access has been made simple and flexible, so little or no training is required. Email and/or in-app notifications guide the participant directly to their surveys, which can be accessed through TrialKit, a free mobile app, or through any web browser
  • Automate the entire notification process and enforce survey completion by sending reminders
  • Allow sites to send manual notifications directly to participants

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