Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia

Vida Terzić, Léa Levoyer, Mélanie Figarella, Elisabetta Bigagli, Noémie Mercier, Lucie De Gastines, Séverine Gibowski, Marius Trøseid, Jacques Demotes, Inge Christoffer Olsen, Maya Hites, Florence Ader, José Ramón Arribas Lopez, France Mentré, Hélène Espérou, Dominique Costagliola, John Arne Røttingen, Julien Poissy, Jean Christophe Rozé, Adilia WarrisJackie O'Leary, Ricardo M. Fernandes, Lambert Assoumou, Regis Hankard, Mark A. Turner, Yazdan Yazdanpanah, Alpha Diallo*, Marius Trøseid, Aleksander Rygh Holten, Andreas Barratt-Due, Inge Christoffer Olsen, Elin Westerheim, Martha Colban, Kristian Tonby, Julien Poissy, Nathan Peiffer-Smadja, Joe Eustace, Ruben E. Keane, José R. Arribàs, Irene Garcia, Fulvia Mazzaferri, Maya Hites, David Grimaldi, Jean Reuter, Therese Staub, Guy Berchem, Christelle Delmas, Juliette Saillard, Claire Fougerou-Leurent, Assia Ferrane, c4c safety group, EU-Response safety group, Alpha Diallo*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review


Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk–benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.

Original languageEnglish
Pages (from-to)1318-1328
Number of pages11
JournalBritish Journal of Clinical Pharmacology
Issue number4
Publication statusPublished - Apr 2023


  • clinical trials
  • drug safety
  • paediatrics
  • pharmacovigilance
  • public health


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