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Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.
Pharmacol Res Perspect. 2023 Jun;11(3):e01072. doi: 10.1002/prp2.1072.
Pharmacol Res Perspect. 2023.
PMID: 37269068
Free PMC article.
Review.
Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia.
Terzić V, Levoyer L, Figarella M, Bigagli E, Mercier N, De Gastines L, Gibowski S, Trøseid M, Demotes J, Olsen IC, Hites M, Ader F, Lopez JRA, Mentré F, Espérou H, Costagliola D, Røttingen JA, Poissy J, Rozé JC, Warris A, O'Leary J, Fernandes RM, Assoumou L, Hankard R, Turner MA, Yazdanpanah Y, Diallo A; EU-Response safety group; c4c safety group.
Terzić V, et al.
Br J Clin Pharmacol. 2023 Apr;89(4):1318-1328. doi: 10.1111/bcp.15669. Epub 2023 Feb 8.
Br J Clin Pharmacol. 2023.
PMID: 36680782
Free article.
Review.
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Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.
Terzić V, Miantezila Basilua J, Billard N, de Gastines L, Belhadi D, Fougerou-Leurent C, Peiffer-Smadja N, Mercier N, Delmas C, Ferrane A, Dechanet A, Poissy J, Espérou H, Ader F, Hites M, Andrejak C, Greil R, Paiva JA, Staub T, Tacconelli E, Burdet C, Costagliola D, Mentré F, Yazdanpanah Y, Diallo A; DisCoVeRy study group.
Terzić V, et al. Among authors: ferrane a.
Clin Infect Dis. 2024 Mar 29:ciae170. doi: 10.1093/cid/ciae170. Online ahead of print.
Clin Infect Dis. 2024.
PMID: 38552208
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Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20-15 DisCoVeRy study.
Fougerou-Leurent C, Delmas C, Saillard J, Dumousseaux M, Ferrane A, Mercier N, Terzic V, Le Mestre S, Dechanet A, Belhadi D, Metois A, Burdet C, Mentré F, Noret M, Diallo A, Petrov-Sanchez V, Couffin-Cadiergues S, Hites M, Ader F, Esperou H.
Fougerou-Leurent C, et al. Among authors: ferrane a.
Contemp Clin Trials. 2023 Aug;131:107267. doi: 10.1016/j.cct.2023.107267. Epub 2023 Jun 9.
Contemp Clin Trials. 2023.
PMID: 37302469
Free PMC article.
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