eCOA

Today’s eCOA demands are wide reaching and require true fit-for-purpose solutions adaptable to the specific study design. The Clinical Ink eCOA suite leverages both the Capture and Engage solutions and supports the full range of eCOA requirements. Whether your trial requires a simple solution for collecting standard patient or clinician reported outcomes (ePRO or ClinRO) or needs full-service structured diagnostic interview and rater-based questionnaire support, Clinical Ink’s eCOA suite has the capability to deliver a true fit-for-purpose eCOA solution.

KEY BENEFITS

Patient portability:

Patients created in Clinical Ink site-based eCOA and ePRO solutions are fully portable across all tablets deployed to a site. This means no management of visits by hardware. This will allow high-enrolling sites freedom for scheduling, regardless of hardware assignment. Active patients can complete questionnaires on any tablet at the site, making schedule management that much easier for high-enrolling sites.

Patient Questionnaire Workflow Support:

Patient visits involving multiple questionnaires can include workflows to decrease patient burden and improve protocol compliance for questionnaire order requirements. Patients confirm their unique PIN and execute the questionnaires required. Questionnaire order will be managed by the application.

Complete ALCOA Compliance:

For full ALCOA compliance, the Clinical Ink eCOA solution manages patient creation with a unique patient created PIN at the first visit where the patient completes activity on the Clinical Ink eCOA tablet with Capture. The Patient Pin is required before patients can execute questionnaires and ensures full attributability. All questionnaires submitted include a full audit trail with PIN authentication detail.

On Device Training:

The Clinical Ink tablet-based eCOA and ePRO solutions for sites fully support training solutions included within the tablet for easy patient and site coordinator-based eLearning and guidance. These trainings help sites and patients in the process of a visit when they need it most and can significantly reduce the need for Help Desk support and frustration on the part of sites in finding the training they need for their patients and for themselves.

A CLOSER LOOK

Familiar Look & Feel

Specifically built as a tablet-based application that mimics the familiar paper-pen interface, Capture was designed to look and feel just like familiar paper documents. Each eSource form can be fully customized and configured according to specific study protocols.

Site-Centric Design

Designed to mimic the natural workflow of research sites, Capture maximizes efficiencies, quality and speed. Ideal for users with any level of research experience, Capture guides proper protocol execution while automatically validating data upon entry.

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