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’s offering greatly reduces the cost and time lags associated with partial image adjudication that result from stand-alone adjudicator system integration. No more trial-by-trial web services and API programing “connectors” that require redundant databases exports, imports and revalidation that increase the potential risk to patient efficacy and data security from external exposure.
“One of the key benefits of the Datatrak platform is our ability to configure features to meet our client’s needs. We ensured his benefit is present in the adjudication feature which will offer clients the ability to configure their workflows, forms, questions, roles and more through our EDC trial design application.” said Niki Kutac, Director Product Management. Offering this configurability and automated process within EDC significantly reduces the time and cost associated with study start-up processes such as, design, validation, as well as mid-study changes, reporting and now endpoint adjudication.”
Expanding our platform to include remote image capture and adjudication was just the next logical step to warehousing and managing CTMS, EDC, ePRO, eCOA and eConsent clinical data within our Enterprise Cloud. “We eagerly anticipate the multiplier effects coming from our 2019 Business Intelligence release which empowers our sponsors to recapture and drive predictive analytics across centralize historical and real-time data.” said Jim Bob Ward, CEO.
About Datatrak International, Inc.
Datatrak International is a worldwide technology and services company delivering unified eClinical solutions and related services for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The Datatrak software solution, deployed worldwide through an ASP or Enterprise Transfer offering, supports Pre-clinical, Phase I – Phase IV drug, device and diagnostic studies in multiple languages throughout the world.
The Datatrak Enterprise Cloud includes the following products: Business Intelligence, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Medical Coding, Risk-Based Monitoring, ECG Data Capture, Image Data Capture, Randomization, Clinical Supply Inventory, Design, eConsent, ePRO and eCOA.