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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Trusting investigator sites to do the right thing

As we all know, investigator sites around the world are the most important partners a sponsor or a lab can have in their quest to determine the efficacy of new therapies. Investigator sites are small groups of committed researchers and trial coordinators who are dedicated not only to improving their patients current medical condition, but […]

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Moving from media to electronic submissions: Five tips every clinical PM should know

An Operations Project Manager at AG Mednet oversees the customization and deployment of AG Mednet’s exam processing and submission technology to its core lab and pharmaceutical/device customers. The set-up of AG Mednet software for an imaging clinical trial begins with a requirements-gathering process for the application build. The Project Manager works with the Operations Engineers […]

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