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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Date: Tuesday 10-November, 2020 Duration: One hour Time: UTC 1500
Presenter: Beatrix Vereijken (Norwegian University of Science and Technology) and Valdo Arnera (ERT Technology)
Mobility is an important marker of health, key to our independence, and a major driver for quality of life. Many aspects of how we walk can be easily measured and quantified in a well-equipped scientific or clinical laboratory, but this ‘artificial snapshot in time’ is a poor indicator of how well we move about in the real world. Recent advances in digital technologies have opened the door to monitoring mobility 24/7 but going beyond the number of steps or the vigour of moving has shown remarkably difficult. Yet, accurate assessment of daily life mobility in clinical trials and patient treatment is necessary for improved and more personalised care, but what is required to get there?
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BoF Round-table: Master Protocol Trial Designs & Data Management Considerations
Facilitator: Sara Hale, Amgen
Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.
BoF Webinar: IMI Mobilise-D -- Measuring and validating real-world mobility – Easier said than done
Technology Showcase: Challenges to the Adoption of Paperless Trials During the COVID-19 Epidemic and Beyond
Presenter: Dr. Jules Mitchel, Target Health
About this Topic: Clearly, the implementation of traditional clinical research studies as well as executing COVID-19 studies themselves. have been dramatically impacted by global COVID-19 pandemic. Since showing up at clinical sites in general is becoming less feasible, clinical research must adapt. While there are many exciting ideas to execute virtual and remote studies, the focus still needs to be on the assurances that 1. the clinical sites understand and are following the protocol; 2. the data can and are being entered and reviewed in “real time,” 3. there are the “absence of errors that matter” and 4. the “data are fit for purpose.” This session will showcase several studies using the Target Health web-based application, with Informed Consent fully integrated with real time direct data capture, real time reports, online monitoring reports and safety reporting.
eCF Technology Showcase: Veeva Systems “End-to-End Clinical Data: Connecting Patients, Sites, and Sponsors”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.