Our Onsite eCOA and ePRO Tablets Offer:
Complete ALCOA Compliance
For full ALCOA compliance, our platform manages patient authentication with a unique PIN created by the patient at their first visit. When the patient completes activity, the PIN will provide a full audit trail with authentication detail and offer the ability to reset workflows without help desk intervention.
Patient Portability
Patient accounts created in our platform are fully portable across all tablets deployed to a site. Patients can complete questionnaires on any tablet assigned to a site, making schedule management easier for high-enrolling sites.
Patient Questionnaire Support
Patient visits involving multiple questionnaires can include workflow support to decrease patient burden and improve protocol compliance. Patients confirm their PIN and execute the first questionnaire, with all subsequent questionnaires launching as required by design, without additional monitoring.
Self Service DCFs & Questionnaire Query Support
Our onsite modules support remote monitoring and querying of questionnaire responses and tablet-based responses, allowing onsite users to see and respond to queries in context.
On-Device Training
We include onboard training solutions for easy patient and site coordinator-based eLearning and guidance. A guided practice study is available on all tablets.
Standard Reports Available Online
All of our onsite studies include a full set of standard reports
by default. These reports can be augmented by further
custom reports as needed or required.
Our Remote ePRO Solutions Offer:
Point and Click Mobile Solutions
Our remote solution is fully configurable. Project professionals are capable of designing, developing, and deploying functional prototypes for testing and review with minimal training.
In-App Patient Training Diary
The Training Diary includes all the standard ePRO Diary Controls. Once complete after the patient’s first visit, it will transmit to the study database with a record of patient training.
Compliance and Conditional Alerting via Email
Questionnaire compliance email-based alerts can be deployed to help sites and monitors proactively engage with patients to ensure compliance goals. Specific conditions to be tracked can trigger alert notifications via email to sites and monitors as needed.
Configurable Scoring and Coding
We simplify the process of scoring and coding for endpoint analysis, screening review, and randomization decisions, mitigating the complexity and setting up teams for success.
Fully Configurable and Sponsor-Specific Library
Our ePRO library supports the creation, locking and importing of questionnaires — meaning no need to repeatedly design, review, control, test, and UAT when deploying the same questionnaires in multiple trials.
Rapid and Regular Prototyping
Using the fully configurable authoring tool, project managers can rapidly design, configure, and deploy prototypes for sponsor and CRO design reviews and approvals, increasing efficiencies and feedback quality.
Standard Reports Online and On Demand
By default, all our deployments include a full set of standard reports. These can be augmented by further custom reports, as needed or required.
Support for All Clinical Trial Phases
Our platform has been deployed with major global pharma across all phases of clinical trials, with translation in more than 40 languages and the ability to support special character sets and right-to-left languages. The application is fully 21 CFR Part 11 and ALCOA compliant.
Support for Provisioned and BYOD
Our platform can be deployed to 1) manage device inventory, logistics planning, and patient device data plans for a provisioned model, 2) support a 100% bring your own device (BYOD) model, or 3) support a mix of both models.
