Participant-centric study design has advanced, but site-centric execution has not kept pace. In the Journal for Clinical Studies, Brian Mallon examines how unclear expectations, administrative burden and contract delays ...
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The importance of partnering for bioanalytical studies
BioPharm International speaks with ICON's Robert Kernstock about the need for bioanalytical testing programs and regulatory strategies for potential new biologics.
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The U.S. biosimilars market: Shaking the “laggard” label
An article by Katya Svoboda and Bob Swann which explores the fundamental differences in the regulatory processes and the market dynamics of the US and the EU which account for much of the discrepancy in the uptake of biosimilars.
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The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety, written by Arinder Sihota and Trupti Gurjar, which featured in the March 2020 edition of Pharma Focus.
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