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TITLE: Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia  Full Text
AUTHORS: Terzic, Vida; Levoyer, Lea; Figarella, Melanie; Bigagli, Elisabetta; Mercier, Noemie; De Gastines, Lucie; Gibowski, Severine; Troseid, Marius; Demotes, Jacques; Olsen, Inge Christoffer; Hites, Maya; Ader, Florence; Lopez, Jose Ramon Arribas; Mentre, France; Esperou, Helene; Costagliola, Dominique; Rottingen, John Arne; Poissy, Julien; Roze, Jean Christophe; Warris, Adilia; O'Leary, Jackie; Fernandes, Ricardo M.; Assoumou, Lambert; Hankard, Regis; Turner, Mark A.; Yazdanpanah, Yazdan; Diallo, Alpha; ...More
PUBLISHED: 2023, SOURCE: BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, VOLUME: 89, ISSUE: 4
INDEXED IN: WOS
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TITLE: 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
AUTHORS: Mercier, Noemie; Belhadi, Drifa; DeChanet, Aline; Delmas, Christelle; Saillard, Juliette; Dumousseaux, Marina; Le Mestre, Soizic; Fougerou Leurent, Claire; Ferrane, Assia; Burdet, Charles; Esperou, Helene; Ader, Florence; Hites, Maya; Peiffer Smadja, Nathan; Poissy, Julien; Andrejak, Claire; Paiva, Jose Artur ; Tacconelli, Evelina; Staub, Therese; Greil, Richard; Costagliola, Dominique; Mentre, France; Yazdanpanah, Yazdan; Diallo, Alpha; ...More
PUBLISHED: 2023, SOURCE: PHARMACOLOGY RESEARCH & PERSPECTIVES, VOLUME: 11, ISSUE: 3
INDEXED IN: Scopus WOS
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TITLE: Association between SARS-CoV-2 viral kinetics and clinical score evolution in hospitalized patients
AUTHORS: Neant, Nadege; Lingas, Guillaume; Gaymard, Alexandre; Belhadi, Drifa; Hites, Maya; Staub, Therese; Greil, Richard; Paiva, Jose Artur ; Poissy, Julien; Peiffer Smadja, Nathan; Costagliola, Dominique; Yazdanpanah, Yazdan; Bouscambert Duchamp, Maude; Gagneux Brunon, Amandine; Ader, Florence; Mentre, France; Wallet, Florent; Burdet, Charles; Guedj, Jeremie;
PUBLISHED: 2023, SOURCE: CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY
INDEXED IN: WOS
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TITLE: Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group  Full Text
AUTHORS: Diallo, Alpha; Troseid, Marius; Simensen, Victoria Charlotte; Boston, Anais; Demotes, Jacques; Olsen, Inge Christoffer; Chung, Florence; Paiva, Jose Artur ; Hites, Maya; Ader, Florence; Arribas, Jose Ramon; Baratt Due, Andreas; Melien, Oyvind; Tacconelli, Evelina; Staub, Therese; Greil, Richard; Tsiodras, Sotirios; Briel, Matthias; Esperou, Helene; Mentre, France; Eustace, Joe; Saillard, Juliette; Delmas, Christelle; LeMestre, Soizic; Dumousseaux, Marina; Costagliola, Dominique; Rottingen, John Arne; Yazdanpanah, Yazdan; ...More
PUBLISHED: 2022, SOURCE: CLINICAL MICROBIOLOGY AND INFECTION, VOLUME: 28, ISSUE: 1
INDEXED IN: Scopus WOS
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TITLE: Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial  Full Text
AUTHORS: Florence Ader; Maude Bouscambert Duchamp; Maya Hites; Nathan Peiffer Smadja; Julien Poissy; Drifa Belhadi; Alpha Diallo; Minh Patrick Lê; Gilles Peytavin; Thérèse Staub; Richard Greil; Jérémie Guedj; Jose Artur Paiva; Dominique Costagliola; Yazdan Yazdanpanah; Charles Burdet; France Mentré; Alexander Egle; Michael Joannidis; Bernd Lamprecht; Antoine Altdorfer; Leila Belkhir; Vincent Fraipont; Gil Verschelden; Jérôme Aboab; Hafid Ait Oufella; Claire Andrejak; Pascal Andreu; Laurent Argaud; Firouzé Bani Sadr; François Benezit; Mathieu Blot; Elisabeth Botelho Nevers; Lila Bouadma; Olivier Bouchaud; David Bougon; Kevin Bouiller; Fanny Bounes Vardon; David Boutoille; Alexandre Boyer; Cédric Bruel; André Cabié; Emmanuel Canet; Charles Cazanave; Cyrille Chabartier; Catherine Chirouze; Raphaël Clere Jehl; Johan Courjon; Flora Crockett; François Danion; Agathe Delbove; Jean Dellamonica; Félix Djossou; Clément Dubost; Alexandre Duvignaud; Olivier Epaulard; Loïc Epelboin; Murielle Fartoukh; Karine Faure; Emmanuel Faure; Tristan Ferry; Cécile Ficko; Samy Figueiredo; Benjamin Gaborit; Rostane Gaci; Amandine Gagneux Brunon; Sébastien Gallien; Denis Garot; Guillaume Geri; Sébastien Gibot; François Goehringer; Marie Gousseff; Didier Gruson; Yves Hansmann; Olivier Hinschberger; Stéphane Jaureguiberry; Vanessa Jeanmichel; Solen Kerneis; Antoine Kimmoun; Kada Klouche; Marie Lachâtre; Karine Lacombe; Fabrice Laine; Jean Philippe Lanoix; Odile Launay; Bruno Laviolle; Vincent Le Moing; Jérôme Le Pavec; Yves Le Tulzo; Paul Le Turnier; David Lebeaux; Benjamin Lefevre; Sylvie Leroy; François Xavier Lescure; Henry Lessire; Benjamin Leveau; Paul Loubet; Alain Makinson; Denis Malvy; Charles Hugo Marquette; ...More
PUBLISHED: 2022, SOURCE: LANCET INFECTIOUS DISEASES, VOLUME: 22, ISSUE: 2
INDEXED IN: Scopus WOS CrossRef: 202
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TITLE: Remdesivir for the Treatment of Hospitalised Patients with COVID-19 (DisCoVeRy): A Randomised, Controlled, Open-Label Trial
AUTHORS: Florence Ader; Maude Bouscambert-Duchamp; Maya Hites; Nathan Peiffer-Smadja; Julien Poissy; Drifa Belhadi; Alpha Diallo; Christelle Delmas; Juliette Saillard; Aline Dechanet; Claire Fougerou; Minh-Patrick Lê; Gilles Peytavin; Noémie Mercier; Priyanka Velou; Sarah Tubiana; Xavier Lescure; Emmanuel Faure; Saad Nseir; Jean-Christophe Richard; Florent Wallet; François Goehringer; Benjamin Lefèvre; Antoine Kimmoun; François Raffi; Bejamin Gaborit; Jean Reignier; Jean-Philippe Lanoix; Claire Andrejak; Yoann Zerbib; Firouzé Bani-Sadr; Bruno Mourvilliers; François Danion; Yvon Ruch; Raphaël Clere-Jehl; Vincent Le Moing; Kada Klouche; Karine Lacombe; Guillaume Martin-Blondel; Fanny Vardon-Bounes; André Cabié; Jean-Marie Turmel; Lionel Piroth; Mathieu Blot; Elisabeth Botelho-Nevers; Amandine Gagneux-Brunon; Guillaume Thiery; François Bénézit; Rostane Gaci; Joy Mootien; Sébastien Gallien; Denis Garot; Kevin Bouiller; Loïc Epelboin; Stéphane Jauréguiberry; Alexandre Gaymard; Gil Verschelden; Sandra Braz; Joao-Miguel Ferreira Ribeiro; Michael Joannidis; Thérèse Staub; Antoine Altdorfer; Richard Greil; Alexander Egle; Jérémie Guedj; Marion Noret; Roberto Roncon-Albuquerque Jr ; Jose-Artur Paiva; Bruno Lina; Dominique Costagliola; Yazdan Yazdanpanah; Charles Burdet; France Mentré; ...More
PUBLISHED: 2021, SOURCE: SSRN Electronic Journal
INDEXED IN: CrossRef: 1
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TITLE: Remdesivir for the Treatment of Hospitalised Patients with COVID-19 (DisCoVeRy): A Randomised, Controlled, Open-Label Trial
AUTHORS: Florence Ader; Maude Bouscambert-Duchamp; Maya Hites; Nathan Peiffer-Smadja; Julien Poissy; Drifa Belhadi; Alpha Diallo; Christelle Delmas; Juliette Saillard; Aline Dechanet; Claire Fougerou; Minh-Patrick Lê; Gilles Peytavin; Noémie Mercier; Priyanka Velou; Sarah Tubiana; Fraçois-Xavier Lescure; Emmanuel Faure; Saad Nseir; Jean-Christophe Richard; Florent Wallet; François Goehringer; Benjamin Lefèvre; Antoine Kimmoun; François Raffi; Bejamin Gaborit; Jean Reignier; Jean-Philippe Lanoix; Claire Andrejak; Yoann Zerbib; Firouzé Bani-Sadr; Bruno Mourvilliers; François Danion; Yvon Ruch; Raphaël Clere-Jehl; Vincent Le Moing; Kada Klouche; Karine Lacombe; Guillaume Martin-Blondel; Fanny Vardon-Bounes; André Cabié; Jean-Marie Turmel; Lionel Piroth; Mathieu Blot; Elisabeth Botelho-Nevers; Amandine Gagneux-Brunon; Guillaume Thiery; François Bénézit; Rostane Gaci; Joy Mootien; Sébastien Gallien; Denis Garot; Kevin Bouiller; Loïc Epelboin; Stéphane Jauréguiberry; Alexandre Gaymard; Gil Verschelden; Sandra Braz; Joao-Miguel Ferreira Ribeiro; Michael Joannidis; Thérèse Staub; Antoine Altdorfer; Richard Greil; Alexander Egle; Jérémie Guedj; Marion Noret; Roberto Roncon-Albuquerque Jr ; Jose-Artur Paiva; Bruno Lina; Dominique Costagliola; Yazdan Yazdanpanah; Charles Burdet; France Mentré; ...More
PUBLISHED: 2021, SOURCE: SSRN Electronic Journal
INDEXED IN: CrossRef