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Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies, Developed by the Inter-Company IMPALA Consortium

Crossref DOI link: https://doi.org/10.1007/s43441-025-00892-x

Published Online: 2026-05-11

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Trevett, Kiernan

Emerson, Jennifer

Walker, Paula

Ménard, Timothé

Koukounari, Mariza

Anderson, Louise

Barlow, Heike

Bridges, Jamie

,
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Text and Data Mining valid from 2026-05-11

Version of Record valid from 2026-05-11
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Article History

Received: 11 February 2025

Accepted: 17 October 2025

First Online: 11 May 2026

Declarations

:

: At the time this article was written, Kiernan Trevett was employed by Genentech, A Member of the Roche Company, Jennifer Emerson was employed by Boehringer Ingelheim, Paula Walker was employed by Roche Products Ltd (Roche), Timothé Ménard was employed by F. Hoffmann-La Roche AG (Roche), Mariza Koukounari was employed by Bristol Myers Squibb, Louise Anderson and Heike Barlow were employed by Bayer, and Jamie Bridges was employed by Merck & Co., Inc.

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