Five Tips for Minimizing Mid-study Change Delays

According to a survey published in Applied Clinical Trials, study changes and their associated delays topped the list of challenges faced while conducting a clinical trial. Mid-study changes and the need to update RTSM design are often inevitable, especially in adaptive trials. However, there are ways to minimize the impact and even embrace this need …

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Veeva introduces Veeva RTSM during EU Summit

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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Protecting the Blind in Clinical Trial Shipments

Striking a balance between effective study drug inventory control and efficient management of inventories and shipping costs is not always easy – especially when you are faced with the real-life complexities of clinical trials. The most efficient ways to manage drug supply are: Automated “Predictive Resupply”: These algorithms are used for studies that have high enrollment, fewer …

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Jumping the Hurdles of Everyday Clinical Trial Challenges

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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Tracking Temperature Deviation with your RTSM

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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Why Flexibility is Important in Clinical Trials Supply — and how a nimble RTSM partner can help keep your trial on track.

changes in clinical trials can be challenging

Why is flexibility important to keeping a clinical trial on track? To illustrate this, let’s explore the Clinical Trial Supply Lifecycle using a fictional Sponsor named Pharzm who is running a Phase 3 trial for a new drug. Pharzm has a new two-year trial, which includes 200 subjects. They plan to manufacture 5,280 bottles of …

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Testing Your RTSM for Your Next Clinical Trial

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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Managing Drug Returns with your RTSM

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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Effective RTSM Startup Meetings – Tips for Sponsors and CROs

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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