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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Clinical trial site queries: How many do we have to live with?

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 timepoint) to incongruences within a single submission (e.g., different documents […]

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The power of notifications in trials with image-based eligibility criteria

  We are seeing more and more imaging trial protocols requiring the analysis of subject eligibility to occur under tightening deadlines. Take for example a cardiovascular study using centralized analysis of an Intra-Vascular Ultrasound (IVUS) to determine whether a subject should be included in the trial. In this particular protocol, the patient remains in the […]

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Is site submission quality less important than data analysis?

Clinical trial sponsors have focused for years on finding the right investigators who can recruit patients, and choosing the best core laboratories to do the necessary data analysis. Without a doubt, having the best thought leaders associated with a trial can increase the level of success (defined as pursuing the right path and abandoning the […]

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Batching image submissions in clinical trials: the case against it!

Clinical trials are inherently risk management exercises, where sponsors, CROs and investigators work as a team to determine the effectiveness of a compound or treatment. In the late 1900s, form data submitted by investigators to CROs was sent using the latest in technology: fax. Prior to that, forms were mailed. The advent of EDC systems […]

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