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OmniComm Systems Inc. announced the immediate availability of TrialMaster version 4.1.2, its flagship product for electronic data capture (EDC). This latest version of TrialMaster introduces Dynamic Monitoring, a feature that allows organizations conducting clinical trials to significantly reduce their monitoring costs, while showing compliance with the FDA's new draft guidance on risk-based monitoring.

This feature allows customers to control how much of the data in a given trial needs to be verified against source documents, such as specifying that half the patients should have full monitoring and half should be monitored for critical variables only. The specification can vary by investigative site, allowing the sponsor or Contract Research Organization (CRO) to focus its monitoring resources to maximize effectiveness.

This new release also features a variety of significant functionality enhancements including: major improvements to the management of laboratory reference ranges, an upgrade to LogiXML version 10 for ad-hoc reporting, the ability to control security at the item level, and a new capability to attach images and other types of files to electronic Case Report Forms. These attached files are also included in the PDFs of patient data that are produced at the end of the study, allowing FDA reviewers to see images and scanned documents alongside the submitted textual data.

"TrialMaster already offers the industry's most intuitive EDC product, providing sites an unequalled level of interactivity," said Keith Howells, SVP of Development at OmniComm. "This new release provides tremendous additional benefits to the sponsor companies, notably allowing them to implement risk-based monitoring plans and thus drive down costs without impacting quality. We are looking forward to a speedy adoption of these new capabilities."

OmniComm Systems Inc.

 

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