On May 15th EMA has released the revised External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use – Version 1.5. EMA also published an accompanying Summary of changes to the ‘External guidance on the implementation of… read more →
Implementing the EMA User Personas Model for the Clinical Trial Information System (CTIS) project, which Maxer Consulting developed and implemented for Zambon, has been successfully completed. The communication, training, and organisational alignment activities have supported the Zambon departments involved in clinical development in familiarising themselves with the CTIS platform processes… read more →
Chiesi Farmaceutici S.p.A. has assigned Maxer Consulting to implement the 2025 Clinical Trial Disclosure and Data Transparency programme in compliance with the regulations in force in the USA. The CTD/DT activities require that Maxer upload the results of a series of clinical studies to ClinicalTrials.gov Protocol Registration and Result System… read more →
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 →
