Electronic Trial Master File (eTMF)
See the following -
Overview of Major eClinical Trends and Clinical Research
Clinical research is well on its way to transforming its paper-driven model to an all things electronic format. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring. This article focuses on the top eClinical trends of 2015 and beyond. Among the latest developments- adoption rates are higher for electronic data capture (EDC), electronic source data (eSource), and eClinical integration, as the focus is now on capturing real-time data as a continuous stream. These trends are partially the result of high-tech devices, sensors and wearables entering the clinical trial industry, as well as the FDA embracing technology and opening up a dialogue with experts on how to best channel this revolution in order to advance clinical research.
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Pharmaceutical And IT Communities Collaborate On OASIS Clinical Trial Data Standard For Content Management Systems
The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.
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