KNOWLEDGE VAULT
The information you will find on this page provide you with a closer look into our progress on identifying, prioritizing, designing and facilitating the implementation of solutions that drive efficient, effective and high-quality delivery of new medicines.
This video highlights TransCelerate's CQMS conceptual framework, which will provide a holistic clinical quality management system, in turn saving time, increasing efficiencies, and ultimately providing a safer experience for patients.
What is a Clinical Quality Management System (CQMS)?
In this video, we highlight the capabilities and benefits of the Study Workspace that helps manage study site information, documentation and open tasks – greatly improving the site-sponsor relationship.
Study Management Made Simple with SIP
Hear from SIP creators and users about the benefits of the platform and how the SIP transforms communication (engagement) between sites and sponsors when planning and executing clinical trials.
The Shared Investigator Platform (SIP): From Concept to Reality
TransCelerate BioPharma Inc. has designed an example of an electronic label, or eLabel, for interaction with Health Authorities to show the “art of the possible.”
The Art of the Possible
Find out what an eLabel is and how the TransCelerate eLabels Initiative will help advance the journey to a digitally-supported, patient-centric clinical supply chain.
What is an eLabel?
This video describes the purpose of the Clinical Trial Registry of the Future concept and the principles of its design.
What is the Clinical Trial Registry of the Future?
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This paper provides a brief overview as to how historical trial data optimizes clinical study design and informs clinical analysis, and how TransCelerate, along with its 19 member companies, is helping streamline this process through the development of DataCelerate, a global and collaborative data sharing platform.
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This article examines the gap between policy change and the evolution of the pharmaceutical landscape. With advances in technology presenting new opportunities for identifying adverse events, the hope is that more relevant data can begin to be obtained from technology that interacts with patients and providers. This article explores how policy change can support developments like these, and how a TransCelerate study is helping to pave the way.
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BioCelerate’s Toxicology Data Sharing (TDS) Initiative was designed with the goal of accelerating long-term vision for non-clinical data sharing, and one step towards achieving this goal was through the development of the shared data platform DataCelerate. This document outlines a long-term vision for non-clinical data sharing, sheds light on the design and build of DataCelerate and its results thus far.
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Initiative Assets
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The Latest
New! Our Protocol Deviations Initiative just launched a brand new assets page, equipped with a PD Process Guide, PD Map and PD Assessment Plan. To visit the page and explore its materials, click here.
To read and download the new paper from our Interpretation of Guidances & Regulations Initiative on the evolving remit of reference safety information, click here.
Our Patient Technology Initiative asked our Member Companies how they implement PT in clinical trials and shared the findings in a white paper available here.
NEW! Read our new paper describing a solution to share historical trial data to enable data sharing & accelerate clinical development across the biopharma industry here.
New! Our Protocol Deviations Initiative just launched a brand new assets page, equipped with a PD Process Guide, PD Map and PD Assessment Plan. To visit the page and explore its materials, click here.
To read and download the new paper from our Interpretation of Guidances & Regulations Initiative on the evolving remit of reference safety information, click here.
Our Patient Technology Initiative asked our Member Companies how they implement PT in clinical trials and shared the findings in a white paper available here.
NEW! Read our new paper describing a solution to share historical trial data to enable data sharing & accelerate clinical development across the biopharma industry here.
