Global life sciences technology company Clinical ink has introduced EDCXtra, a new electronic data capture (EDC) system for clinical trials.
The system integrates direct data capture (DDC), electronic clinical outcome assessments (eCOAs), and electronic consent (eConsent) solutions into a single web-based application.
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The platform is designed to streamline the data capture process in trials, offering a comprehensive and good clinical practice (GCP) compliant solution.
EDCXtra builds on Clinical ink’s existing DDC/eSource platform, which has been developed over 17 years and is said to have contributed to multiple FDA approvals.
The new system aims to enhance clinical trial data management by consolidating all DDC functionalities.
Its hybrid mode allows for real-time data entry of case report form (CRF) data and complex eCOAs through a unified interface.
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By GlobalDataThis flexibility also extends to sites that prefer to use paper CRF transcription methods, with the option to enter data into the EDC at a later stage.
In addition to its core features, EDCXtra provides eConsent capabilities and can be integrated with other eClinical systems, including interactive response technology (IRT) and laboratory data.
The system’s customisability ensures it can be personalised to meet the specific demands of each clinical trial, the company noted.
Clinical ink focuses on merging data, technology, and patient-centric research to support advanced trials.
It has expertise in therapeutic areas, combined with its suite of EDC, DDC, eCOA, eConsent, telehealth, and digital biomarkers, including blood and continuous glucose monitoring for hypoglycemia detection.
Clinical ink clinical operations EVP Megan Petrylak said: “We developed EDCXtra to improve the site experience by providing a single flexible EDC/DDC solution.
“The integration of EDCXtra in our end-to-end eClinical suite improves speed and quality of data capture while significantly reducing the administrative burden on sites. Sponsors benefit from the simplicity and cost advantage of a single study build for EDC and complex eCOAs, as well as the customisable integration of third-party data systems, such as IRT and central laboratory.”
