In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry.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

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...

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...

If you look at a typical proposal for the management and data analysis of image data in clinical trials, there is always a budget item related to site queries. Queries can be generated for a variety of reasons, ranging from missing data (e.g., a missing...