On 22 July Massimo Zaninelli, CEO of Maxer Consulting, presented the training session dedicated to “Clinical studies: from submission to AIC” to the young participants of Missione MSL. The lecture outlined the overview of the process that leads from the design of a study to the marketing authorization of the… read more →
With the kickoff meeting on March 4th, Zambon S.p.A. started the implementation of the “EMA User Personas Model for the CTIS” project, the organization of which is entrusted to Maxer Consulting. The project, with its focus on communication, training, and organizational alignment activities, is designed to prepare Zambon to manage… read more →
We are pleased to announce that EryDel S.p.A., now part of Quince Therapeutics Inc., has appointed Maxer Consulting to deliver its Clinical Trial Disclosure and Data Transparency program for 2023-24. Maxer will carry out the activities necessary to ensure Erydel’s compliance with both the regulations in force in the European… read more →
We are pleased to announce that Dompé S.p.A. has entrusted Maxer Consulting with implementing the Clinical Trial Disclosure and Data Transparency (CTD/DT) program for 2023-24. CTD’s activities require Maxer to ensure compliance by Dompé with the regulations in force in the European Union (EU Reg. 536/2014) and the United States… read more →
As part of the 2023 consultancy activities on Clinical Trial Disclosure and Data Transparency, Zambon S.p.A. asked Maxer to provide the course entitled “ClinicalTrials.gov and CT.gov PRS Modernization”. The course, held on 23 April, touched on the following topics: Modernization of ClinicalTrials.gov Beta version update process Beta versions of ClinicalTrials.gov… read more →
We are pleased to announce that last March Italfarmaco S.p.A. appointed Maxer Consulting to carry out its Clinical Trial Disclosure (CTD) and Data Transparency activities for 2023. The agreement provides for Maxer to ensure Italfarmaco’s compliance with the results of the clinical studies entrusted to Maxer by publishing them on… read more →
Il 14 marzo Erika Ornago e Massimo Zaninelli hanno partecipato in qualità di relatori alle Serate di aggiornamento in medicina e patologia orale, organizzate dal professor Francesco Spadari, responsabile dell’Ambulatorio di Patologie e Medicina Orale presso l’Ospedale Maggiore Policlinico Fondazione Ca’ Granda IRCCS-Milano. La relazione di Ornago ha trattato la Trasparenza degli studi… read more →
On November 21, Erika Ornago and Massimo Zaninelli created the training program dedicated to the EMA Clinical Trials Information System (CTIS) and the User Personas model for the Clinical Operation Team of Erydel S.p.A. The first part of the course summarized some concepts and processes of CTIS, while the second part… read more →
Maxer has implemented a programme to help commercial and non-commercial clinical trial sponsors get accustomed to the EMA Clinical Trial Information System (CTIS).and The programme also supports the update of the sponsor’ organisation models to the CTIS requirements. The programme includes two training sessions– the first is dedicated to… read more →
On 28 and 29 June, Erika Ornago and Massimo Zaninelli (Maxer Consulting) performed for Dompé S.p.A. the “Working with CTIS” training programme, which focuses on the EMA clinical trial information system. The Clinical Operations and Regulatory Affairs teams of Dompé participated in the two sessions. The participants fueled a lively debate on critical… read more →
