Intuitive Electronic Patient Reported Outcomes (ePRO)

The electronic capture of self-reported, patient data plays a critical role as primary and secondary endpoints in clinical research. Sponsors now have access to first-hand, reliable data from which to measure clinical effectiveness assess quality of life, recruit patients, collect and monitor safety information and ensure medical compliance. Not surprisingly, the number of studies leveraging ePRO technology has been steadily increasing over recent years and continues to benefit from high patient acceptance.agoutcomes

agOutcomes is an intuitive, electronic diary solution designed to allow patients to enter data directly on any mobile device – including iPhone, iPad, tablet PCs, Android devices and others. A complete ePRO solution, agOutcomes provides sponsors higher quality data with accurate timestamps and real-time data access.

Seamlessly integrated with ArisGlobal’s agCapture (EDC), agOutcomes enables sponsors to deploy traditional EDC or ePRO studies using the same study builder as well as offering hybrid options.

agOutcomes is an advanced ePro system that can run standalone or fully integrated with a traditional EDC study

Flexible and Configurable Architecture

With the ability to program any device, agOutcomes notifies patients automatically when intervention is required, virtually eliminating potential compliance problems. Its functional online system prevents data loss when working on a device, and any study update or change is immediately seen by patients. The ability to have agOutcomes capture data from a variety of different devices allows the right technology to be used based on the study and patient demographics:

agOutcomes offers other features including:

Flexible and configurable system architecture allowing for simple, fast and effective system adjustments

Ability to complete e-surveys to capture customer satisfaction data

Configurable page layouts to utilize larger devices

A wide variety of compatible devices including computers, smart phones and tablets/slates to accommodate diverse patient needs

Configurable alarms and question workflow that improves compliance and data quality

Real-time notifications for quick identification and response to patient conditions

Proactive patient reminders via outbound calls, SMS and email

Immediate data availability in agCapture (EDC) when used as a nested or unified eClinical solution

Dynamic views

Data import and export functionality

SAS export capabilities

agOutcomes enables organizations to control the management of their patient reported data through many benefits:

Enables more efficient study management

Provides real-time access to first-hand study data, reporting and notifications for quick identification and response to patient conditions

Monitors study progress across multiple sites

Ensures enrollment and timeline goals are met

Enables monitors to focus on protocol compliance rather than time-consuming review of paper diaries

Allows coordinators to be more responsive in managing patient enrollment and compliance

Improves patient relations, as subjects become more motivated and invested in their study participation

Achieves higher compliance from global patient populations

Reduces trial timelines

Enhances usability with device-agnostic flexibility and customizable page layouts