Oracle Health Sciences announced the availability of Oracle Health Sciences InForm Global Trial Management (GTM) 5.5, which includes powerful new functionality to help trial sponsors and clinical research organizations (CROs) improve clinical trial efficiency and increase the productivity of study managers, monitors, and clinical data managers.
Oracle Health Sciences InForm GTM 5.5 offers a significant step forward for the industry with its flexible and dynamic Data Viewer, a new user interface that moves beyond the limitations of traditional electronic data capture solutions and enables greater insight and provides increased support for sponsor roles. Specifically, the Data Viewer provides:
Real-time data listings with sophisticated filtering capabilities to facilitate review across subjects, visits and sites, as well as providing the ability to highlight new or updated data. This capability provides users with full control of the data to speed operational and clinical review, and enables expanded remote data monitoring that increases productivity of site monitors.
The ability for users to take immediate and direct action on data as part of the review process – such as bulk query creation, source verification, and freeze and lock – to significantly increase user productivity.
Advanced displays that help highlight trends, as well as a data comparison tool that enables users to easily examine data for one or multiple subjects.
Oracle Health Sciences InForm GTM 5.5 delivers partial source validation (PSV) as a fully embedded feature, enabling study managers to apply intelligent sampling strategies for validation that help ensure high quality data while reducing monitoring costs and improving overall efficiency of the clinical trial process.
Users can track and conduct source verification directly from the Data Viewer, which streamlines workflow and eliminates the need to access each individual form.
The new release’s expanded workflows and configurable review states support increased automation and efficiency in setting up and managing trials. Sponsors and trial managers can define multiple review points in the system and manage workflows within those windows throughout the trial process. For example, sponsors can set up a medical review workflow within the broader trial, or specify various review gates at certain points in a study.
Oracle Health Sciences InForm GTM 5.5 also includes enhancements to its embedded standard and ad hoc reporting capabilities, including real-time data availability that eliminates issues traditionally caused by data lag.
Oracle Health Sciences Inform GTM 5.5 is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud to help customers accelerate IT deployments, reduce resources required to maintain IT infrastructure and gain a more predictable IT spending pattern.
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