FDA draft guidance and clinical trials

In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry. According to the FDA, the purpose of the guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. More specifically, the guidance focuses on imaging acquisition, display, archiving and interpretation process standards.

After reviewing the 1276-line guidance, the FDA’s recommendations are clear: stronger standards regarding imaging endpoint process standardization for all clinical trials.

At AG Mednet, we’ve been mandating those standards for years with sponsors, core labs and CROs in an effort to make zero-delay clinical trials a reality.

Check out the draft guidance here and let us know how you think this will affect the clinical trial industry. Feel free to share your comments with us on Twitter @AGMednet. To see how AG Mednet’s technology answers the industry guidance, please view the SlideShare below.


[slideshare id=51231486&doc=agfdaslideshare-150803190428-lva1-app6892]

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