e-Patient Reported Outcomes

e-Patient Reported Outcomes

Acceliant's experienced teams help companies electronically collect data directly from the patient, caregiver, and/or clinician for all types of clinical outcome assessment including Patient Reported Outcomes (PRO).

  • Paper, electronic, and mobile from a single trial design Integrated with Acceliant EDC for instant access but trial team
  • Unified CRF including PRO pages with regular study pages (site collected)
  • Trial portal including trail-specific educational content
  • User-friendly interface
  • Patient portal including messaging, alarms, and notifications to patient
  • Unique, multi-faceted CRF rendering for patient use vs. site/CRO/sponsor
  • Mobile support on most mobile platforms including Android, iPhone, iPad, and Blackberry
  • Support for VAS and large visual scales
  • Enables seamless mid-study changes
  • Multi-lingual
Reliable and attributable data
  • Front-end edit checks and range rules
  • Branching logic and protocol-specific workflows
  • Real-time calculations as subjects enter data
100% integration with Acceliant EDC

Acceliant unique EDC/ePRO integration is the most sophisticated in the industry providing two way data flow between the EDC and ePRO modules. This guarantees data consistency as well as provides a unified audit trial for all captured data. Other vendor to vendor integration lacks such benefits.

Standard data management for ePRO

As the site, patient, and CRO/sponsor interaction are critical to the success of a study, Acceliant common data management processes provide the team with unrivaled consistency between data management of ePRO data and CRF data. This ability provides a unique value add that no other system can provide as it reduces the learning and use of a different system for ePRO and EDC. Additionally, Acceliant is the only system that provides a combined view of ePRO and EDC.

  • Reporting. Create global, regional, and site-specific reports by sorting data by study, site, patient, questionnaire, individual question, and response parameters
  • Export Engine. Easily configure study-specific exports and download to your computer using Excel, CDISC, XML, CSV, and PDF without contacting Trianz
  • Compliance Reporting. Quickly identify outliers and intervene to improve compliance, retention, and safeguard data precision and accuracy
  • Query Management. Conduct a data query and change process with ease for both ePRO and CRF data using the same process
  • Data Locking. Follow the same data-locking process for both EDC and ePRO CRFs with Acceliant to make data managers time more efficient and make data available faster than incongruous systems

Selecting the right device, method choice, and diary design are essential elements in ensuring your study data are collected accurately, per protocol, and within budget. Trianz, in close collaboration with its consulting partners, provides the following services to support every ePRO project in clinical trials and other studies:

  • Strategic consulting on instrument and platform selection to best suit each trials' needs
  • Review of usability and validity of the interface and questionnaire wording during requirements development and design
  • Recommendations regarding the need for additional psychometric validation work to support the electronic version of the instrument in regulatory submissions

Additionally, Acceliant will conduct validation studies including usability testing, content validation, cognitive debriefing interviews, and quantitative equivalence testing as needed.

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