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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The ability to track the temperature excursions of an investigational product has become increasingly important in clinical trials. Temperature data logging devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically …
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Drug accountability is important to gathering quality data as well as ensuring patient safety. The problems associated with it remain key issues for clinical trial management in 2022. Using an RTSM (IRT/IVR/IWR) system to manage the distribution and assignment of an investigational product (IP) is a well-established practice. Most RTSM systems include some method of …
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An RTSM system is the tool of choice for clinical trial subject randomization and management, drug assignment, and inventory control. The RTSM system is often the first point of entry for subject data before it is pushed to the EDC housing the clinical database. So when it’s time to hold the startup meeting with your …
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Give Your Clinical Study Team More Power! In the fast-paced world of clinical trials, immediate access to information and the ability to adapt are critical. That’s why Veeva RTSM advocates a “study-team-centric” model of clinical trial execution, where our system facilitates putting the study team in control. To be team-centric means to consider the basic …
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The Clinical Trials industry has seen its share of changes over the past 20 years (like many industries). In case you are keeping score, or trying to keep score, this blog should clarify things a bit. IVR or IVRS (Interactive Voice Response System) is a tool used in the 1990s/early 2000s to call into a …
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