Change is a constant challenge in the world of clinical studies, and it can cause both stress and delays. In our last blog, we discussed 5 tips for more effective mid-study changes. Now let’s look at the components of a successful management process for a technical change from an IRT perspective. The IRT Project Manager …
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Drug accountability is important to gathering quality data as well as for insuring patient safety. The problems associated with it remain key issues for clinical trial management in 2021. Using an IRT (IVR/IWR) system to manage the distribution and assignment of an investigational product (IP) is now a well-established practice. Most IRTs include some method …
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Intuitive and user friendly To be effective, an e-clinical solution must be intuitive for all users. For a clinical system to be user-friendly, it needs to be flexible. As clinical trials move more towards virtual environments, it is extremely important to have views of subject data and information that fit the needs of everyone involved …
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Will you be looking for a new Clinical IRT Partner in 2021? Check out our vendor selection guide! Developed especially for Sponsors, CROs, and Clinical Suppliers, it lists the capabilities and issues to consider when vetting IRT vendors and systems in an easy to use format. We hope you’ll find it useful. Download your …
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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 …
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By Noah Cotes, Project Manager at Veracity Logic, LLC In the fast-paced world of clinical trials, a lack of information and ability to adapt will leave you in the dust. To address this, Veracity Logic advocates a “study-team-centric” model of clinical trial execution, where our system facilitates putting the study team in control. To …
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By Andi DeStefano, Director of Project Management at Veracity Logic, LLC. To see why flexibility is important to keeping a clinical trial on track, let’s explore the Clinical Trial Supply Lifecycle using a fictional Sponsor named Pharzm, who will be running Phase 3 trials for a new drug. Pharzm has a new two-year trial, which …
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Are you wondering if you should use an IRT (IWR/IVR) for your next clinical trial? Perhaps in past trials, the IRT you used had limited features and just wasn’t worth the cost and hassle. If this is the case, take another look. During a clinical trial, site users record activities for subjects; a well-designed IRT …
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This is the first of our on-going FAQ series on IRT services in Clinical Trials. You can listen to the recording or read the text below. In April 2020, a client asked: Can your system handle multiple randomizations for a subject at different points during a study? That is, can the subject be randomized to …
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The Basics: IRT stands for Interactive Response Technology; it uses the web or phone to allow users to interact with a system. A Clinical IRT is a web-based tool for managing subjects and inventory during a clinical trial/study. It allows the clinical research site users (including Primary Investigators, Sub-Investigators, and Study Coordinators) to: add subjects to …
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