Improve data management to improve endpoint adjudication success in clinical trials

In the winter issue of International Clinical Trials, CEO Abraham Gutman writes about how poor management of data is one of the factors ailing adverse event and endpoint adjudication in clinical trials. The clinical trial industry is transforming, and the vision for this is simple: embrace quality and automation across the clinical trial spectrum and […]

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Unique Needs for Medical Device Clinical Trials

AG Mednet’s Brian Kelly joins experts from Oracle to address data quality and compliance in medical device trials during this upcoming webcast. The webcast – Adaptive Medical Device Trials for Fast, Seamless and Accurate Research – takes place Thursday, January 25, 2018, noon EST. Medical device studies are complex and unique, with evolving regulatory oversight […]

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FDA draft guidance and clinical trials

In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry.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, […]

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To be or not to be… compliant

There are a number of challenges when designing and building solutions for the collection and delivery of image submissions for clinical trials. One of them is compliance with global regulations governing the process. While regulations set forth by agencies such as the FDA, HIPAA, and their equivalents in Europe and Asia can be complicated, and […]

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Should BMW focus their R&D on developing new stereo systems?

There is a lot more riding on the success of an imaging trial today than ever before. The world economy, mergers and acquisitions, the state of sponsors’ pipelines and changes in the regulatory environment, have created the most demanding market for clinical trials ever. One of the results of this evolution is the increased focus […]

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