veristat Infographics
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FDA Expedited Pathways
4/27/2021
The FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies. This infographic highlights the benefits of, qualifying criteria for, and timing and procedures for six different expedited programs and designations. Overall, the purpose of these regulatory pathways is to save time and reduce the cost of bringing therapies to market for serious conditions and unmet medical needs.
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The Time For Virtual Trials Is Now
4/27/2021
Over the past few years, this shift has focused on the idea of bringing the clinical trial to the patient's home, an evident disruption of trial conduct today. Download the infographic to learn how virtual trials are defined, the tool kits required to run a virtual trial, examples of what the patient experience can look like, and an understanding of the benefits that ultimately improve clinical trial efficiency.
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Considerations For Natural History Studies
11/17/2020
One of the cornerstones of developing therapies for rare diseases is the use of natural history (or noninterventional) data to help inform the clinical development process. Though you may think natural history studies aren’t relevant or valuable to your clinical program, natural history data can play a surprisingly helpful role in the clinical development process, with many potential uses and benefits.
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Benefits Of A Central Site Model
11/2/2020
A centralized site model allows patients to be treated at one or two central sites, which minimizes the travel burden on patients and caregivers. A combination of technology and/or mobile staff are employed to conduct follow-up visits in a convenient local setting or at the participant’s home. Benefits include greater consistency and operational efficiency that is more manageable and save costs.