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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Though this is the first year since Veeva acquired Veracity Logic to form Veeva RTSM, the team and system have a 16-year history of successfully partnering with sponsors and CRO’s, helping them simplify subject management, randomization, and trial supply. The system is fast, intuitive, and complete – its modular and highly configurable design system allows …
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The Veeva Summit is a customer-focused conference where industry leaders can join to share best practices around the implementation and use of Veeva Products. This year was the Veeva RTSM team’s first Summit experience. We asked them how it went, and here is what they said about their experience: What was your impression of …
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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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I’ve just attended my first in-person Veeva EU Summit event. It was inspiring to see the energy, enthusiasm, and passion from the Veeva customers and my colleagues in Zurich. Jim Reilly, VP of Development, Veeva Cloud Strategy, introduced Veeva RTSM to the audience during the opening keynote session. That kicked off the incredible flurry of …
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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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