Regulatory requirements make the documented testing and validation of the electronic systems used in clinical trials critically important to the success of any clinical study. This is because approval authorities will reject clinical data collected by what regulators deem to be substandard means. (For examples, see 21CFRPart11 and EU Annex 11) There are two categories of project-level RTSM …
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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 Challenge: As technology becomes more and more sophisticated, data collection systems for clinical trials are at risk of becoming less intuitive for users. The challenge for the pharma-tech industry is obvious: how to deliver more power while remaining user-friendly for the diverse population of users at clinical sites around the world. The Solution: …
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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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