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eCOA

Get on the path to cleaner data and better insights for more confident decision-making with configurable, fit-for-purpose solutions that are adaptable to your specific study design. The Lumenis™ eCOA and ePRO modules build up to an ecosystem that 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, Lumenis has the capability to deliver a true fit-for-purpose solution spanning numerous therapeutic areas. With support from Clinical Ink’s team of experienced specialists and the option of leveraging your existing infrastructure and resources to support the solution, getting started is simple.

KEY BENEFITS

Patient Portability:

Patients are fully portable across all tablets deployed to a site. This means no management of visits by hardware — allowing high-enrolling sites the freedom of scheduling, regardless of the hardware assignment. Active patients can complete questionnaires on any tablet at the site, which makes 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, Lumenis manages patient creation with a unique patient-created PIN at the first visit where the patient completes an activity on the tablet. 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:

Training solutions are 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 and can significantly reduce the need for helpdesk 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, we designed Lumenis 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, Lumenis maximizes efficiencies, quality, and speed. The technology is ideal for users with any level of research experience and guides proper protocol execution while automatically validating data upon entry.

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