Introduction As Sponsors look to leverage technology in clinical trials to help maintain and control adherence to the design, methodology and all aspects of a protocol, they are often left with only two functionality options to control protocol deviations. They can leverage Soft Stop functionality where a warning message is shown, providing information that may …
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I recently attended the Clinical Trial Supply Europe conference with my colleagues Romain Arnaud, Glen Fisher, and Jennifer England. It was wonderful to connect with both familiar and new faces on a whole host of clinical supply topics. The team had so many thoughts and ideas coming out of this that it was difficult to …
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Current Challenges In a recent webinar, we asked the audience to highlight the challenges they have with randomization and trial management in their clinical trials. The word cloud below was generated as the participants entered their challenges verbatim. These are issues that have plagued the RTSM space for decades: integrations, help desk issues, study updates, …
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As an RTSM partner, Veeva RTSM works with sponsors and CROs to implement our solution for new studies. Sometimes, however, we are called on to help with unique scenarios involving studies that have already begun recruitment, such as the following: The study started collecting RTSM data in a simple solution (maybe even Excel), but the …
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Despite your team’s careful planning, unexpected road bumps can occur when a clinical trial is in the field. We hope none of these happen to you, but here’s how a nimble RTSM would help you handle these situations. Someone left the package out in the heat! Problem: Your drug must always remain within a …
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