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.
Explore
mc-resource
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
Explore
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.
Explore
July 14, 2020
Initiative Overview – Protocol Deviation
Provides an overview of the initiative and details the journey of asset development
Explore
July 14, 2020
Initiative Overview – Investigator Registry
This overview provides background and history of the Investigator Registry, the definitive source for investigator profile information for the Shared Investigator Platform
Explore
July 14, 2020
eBook
Detailed compilation of the core use cases for sharing of historical trial data (controls) to add value to the design, development, or interpretation of clinical programs.
Explore
July 14, 2020
Initiative Overview – eSource
This overview provides background of the eSource initiative seeking to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.
Explore
July 14, 2020
Initiative Overview – eConsent
Overview of the eConsent Initiative, which aims to create general awareness and enable broad, voluntary implementation of eConsent. The eConsent Initiative has developed practical guidance and tools describing potential implementation considerations and eConsent components.
Explore
July 14, 2020
Case for Adoption of eConsent
This slide deck aims to provide a tool for TransCelerate Member Companies (MC) to create a cohesive business case for eConsent implementation at their companies.
Explore
July 14, 2020
Initiative Overview – Comparator Network
This Overview Deck aims to provide reviewers with a high-level understanding of initiative, why it was developed, its history, how transactions work within the network, and the value by member company participants realized since inception.
Explore