August 3, 2022
Six of TransCelerate’s initiatives were featured in the news during the second quarter of 2022. These stories spanned our strategic priorities, whether it was in relation to patient-centric initiatives, those focused on data, or ways to improve a site’s burden. Read on for a deeper dive. How TransCelerate is impacting biopharma R&D Since the beginning…
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October 12, 2021
Join us for a session discussing RWD/E and considerations for establishing QMS framework and to understand the challenges of applying GCP requirements to this context with speaker Lynette Aldrich (Eli Lilly).
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August 3, 2021
The R&D ecosystem is tasked with developing medicines that will help improve the health of people around the world. Yet often the patients participating in clinical trials are not representative of the population impacted by the disease that is being studied. To safely bring medicines to all people, clinical trial processes need to evolve to…
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November 10, 2020
The Clinical Content & Reuse (CC&R) initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents (e.g., Common Protocol Template, Statistical Analysis Plan, and Clinical Study Report) that can be reused throughout the project lifecycle to enable digitization and traceability through automation. The initiative’s guiding principles include a…
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September 29, 2020
This webinar took place on October 29, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Join us for a panel discussion as experts explore how TransCelerate’s Quality Management System, Risk-Based Monitoring, Quality Tolerance Limits, and Protocol Deviations (e.g. Quality Quartet) initiatives can help…
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September 29, 2020
The Interpretation of Clinical Guidances & Regulations Initiative shares expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and Health Authority operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-life impact of ambiguous regulations/guidelines. While addressing these aims, the initiative will consider the highest…
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