August 18, 2020
Initiative Overview – CRA
Provides an overview of the initiative and details the journey of asset development.
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August 18, 2020
Initiative Overview – Common SAE
Provides an overview of the initiative and details the journey of asset development.
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July 30, 2020
TransCelerate Overview Deck
This is an overview of the TransCelerate organization and its portfolio of projects.
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July 14, 2020
Initiative Overview – Shared Investigator Platform
This overview provides background and history of the Shared Investigator Platform (SIP), which reduces the burden on investigative sites by providing them with a central point of access, harmonized content and services, and streamlined interaction with participating clinical trial Sponsors.
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July 14, 2020
Case Study 5
This case describes the journey taken by one Member Company as a result of a merger and the collective desire to simplify and harmonize cQMS documents in the QMS to effectively develop one global process for the collection and tracking of documents required for initiation of study sites.
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July 14, 2020
Case Study 4
Utilizing the QMS, the author of this case study focused on Issue Management and describes the journey of how the R&D organization evolved in this area with the desire of reducing issues that matter over time.
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July 14, 2020
Case Study 3
The author of this case study describes the journey of leading the strategic development of a cQMS within the R&D organization in a large global Pharmaceutical company.
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July 14, 2020
Case Study 2
This case study describes a QMS-focused initiative by a Member Company to adapt an approach to working with local CROs using parts of the TransCelerate cQMS framework.
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July 14, 2020
Case Study 1
This case study describes how one Member Company utilized TransCelerate Processes model framework, enabling it to shift to a risk-based approach for determining document types, reduce the number of document types, establish quality and compliance support structures and achieve total time savings of 225 hours a year (6-working weeks) through implementation of the model
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July 14, 2020
Initiative Overview – QMS
This deck provids readers with an understanding of why the QMS initiative was initiated, the problem it aims to solve, available tools and materials to facilitate operational implementation and the value realized by member companies since inception.
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