Datatrak International, Inc. Announces Electronic Data Capture System
February 12, 2019 at 02:23 pm EST
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Datatrak International, Inc. announced the Electronic Data Capture (EDC) system to unify medical image capture, display, storage, and adjudication through their Enterprise Cloud platform. Combining remote image capture and endpoint adjudication within a centralized EDC system using one source code and database has been an ongoing industry goal for years. Datatrak has streamlined the FDA guidance of April 2018 with remote image capture, analysis and annotation that incorporates image data and analysis data into clinical trial Electronic Case Report Forms (eCRFs) with role-based access to patient, site, study, and clinical program files. The benefits of CFR 21 compliance can now be advanced with the unification of adjudication workflows and eCRFs which can trigger all conceivable quality checks upon image capture and/or adverse events. These intelligent workflows can be configured to meet all adjudication charter specifications necessary for resolving assessment discrepancies between blinded independent reviewers Clinical Endpoint Committees (CEC) oversight.
Datatrak International, Inc. is a technology and services company. The Company is engaged in delivering global eClinical solutions for the clinical trials industry. The Company is focused on providing subscription and professional services. Its enterprise platforms include Decentralized Trials (including, electronic consent (e-Consent), electronic patient reported outcomes (e-PRO) and electronic clinical outcomes assessment (e-COA), electronic data capture, clinical trial management system (CTMS) and imaging and endpoint adjudication, randomization, and business intelligence. The Companyâs CTMS includes functions for site feasibility and the tracking of action items and milestones. Its imaging and endpoint adjudication is a streamline the approach for managing imaging components while reducing manual workload and errors. Its business intelligence offers solution to create, monitor, and analyze user research and providing insights that allow to optimize processes from all aspects.