Introduction A main goal of Phase 1 trials is to establish the recommended dose and/or dosing regimen of new drugs for efficacy testing in Phase 2 trials, using a detailed and monitored dose escalation process. To reach this endpoint, study designs will have many components of this process outlined in the protocol, including starting dose/regimen, …
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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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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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You may have heard about how easy it is to navigate the Veeva RTSM system. To illustrate this, we’ve added an overview demo video to our resources page. This video guides a site user through the key pages of the system. This video guides a site user through the key pages of the system. In …
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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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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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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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