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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Media
This feature article hallmarks the 2018 launch of DataCelerate, a global technology data sharing platform. The article highlights how the platform can provide insights around preclinical toxicology and placebo and standard of care data contributed by Member Companies. The article also features use cases from TransCelerate’s member companies that showed how access to the platform maximized efficiencies in the clinical trial process.
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The Regulatory Affairs Professionals Society (RAPS) published an article on the collaboration of TransCelerate’s subsidiary BioCelerate and the US Food and Drug Association (FDA). The article provides a brief overview on the joint working group comprised of BioCelerate and the FDA’s Office of Computational Science (OCS) and highlights the two BioCelerate initiatives this collaboration builds on: the SEND Implementation for Cross-Study Analysis and the Common Template for Nonclinical Studies.
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TransCelerate’s new initiatives launched 2019 are highlighted for their analytics goals that aim to boost both time savings and quality in generating results. These initiatives include Modernization of Data Analytics for Clinical Development, Common Clinical Serious Adverse Events Fields and the Interpretation of Guidances and Regulations.
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Initiative Assets
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The Latest
We have a new podcast from our Member Company, Merck & Co., Inc., on the value and implementation of a clinical QMS.
TransCelerate implores representatives for regulatory authorities to work with industry sponsors, in the spirit of ICH, to identify potential ways to re-harmonize global pharmacovigilance processes and requirements. Read it here.
In a recently published article, the Patient Technology Initiative describes the potential for patient-facing digital technologies to serve a variety of functions in clinical trials.
The eLabels Initiative recently launched a new Design & Delivery Toolkit, as well as other educational materials. Check out the assets page to access this helpful information.
We have a new podcast from our Member Company, Merck & Co., Inc., on the value and implementation of a clinical QMS.
TransCelerate implores representatives for regulatory authorities to work with industry sponsors, in the spirit of ICH, to identify potential ways to re-harmonize global pharmacovigilance processes and requirements. Read it here.
In a recently published article, the Patient Technology Initiative describes the potential for patient-facing digital technologies to serve a variety of functions in clinical trials.
The eLabels Initiative recently launched a new Design & Delivery Toolkit, as well as other educational materials. Check out the assets page to access this helpful information.
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