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Authors
Smith, Lucinda
Glaser, Michael
Kempf, Dieter https://orcid.org/0009-0006-2611-8826
Roman, Xaymara
Artlich, Charlotte
Patel, Mayur A.
Bate, Andrew
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Funding
Funding for this research was provided by:
TransCelerate
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Article History
Accepted: 20 February 2025
First Online: 8 March 2025
Declarations
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: TransCelerate BioPharma Inc. supported work on modernizing ICSR management, which led to the co-authors writing this manuscript.
: Lucinda Smith and Dieter Kempf are Roche employees and stockholders. Michael Glaser and Andrew Bate are GSK employees and stockholders. Xaymara Roman is an employee of Astellas. Charlotte Artlich is an employee at Bayer AG. Mayur Patel is an employee and stockholder of AstraZeneca. Andrew Bate is an Editorial Board member of Drug Safety. Andrew Bate was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: All authors drafted, read, reviewed, and approved the final manuscript. LS, DK, and XR provided workstream leadership. MG developed the conceptual architecture in 2023 with assistance from CA and a more recent collaboration from DK. MP and AB provided executive sponsorship throughout the process.
: The perspectives and opinions expressed by the authors are their own and do not necessarily represent the perspectives and opinions of their respective companies.
