On April 28, new legal transparency requirements for clinical trials came into force in the United Kingdom. There are three main changes: The trial must be made public in a dedicated registry before enrolling the first patient, or within 90 days of approval. Results must be published within 12 months… read more →
As of December 31, 2025, the Food & Drug Administration (FDA) had sent 226 Pre-Notices of Noncompliance and 8 Notices of Noncompliance to sponsors (companies and researchers) who failed to publish the results of their studies (Applicable Clinical Trial)) registered on ClinicalTrials.gov within the timeframe required by current regulations. These… read more →
Chiesi Farmaceutici S.p.A. has confirmed Maxer Consulting’s mandate to implement the 2026 Clinical Trial Disclosure and Data Transparency program, in line with current US regulations. The CTD/DT activities require Maxer to upload the results of a series of clinical trials to ClinicalTrials.gov Protocol Registration and Result System in accordance with… read more →
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 →
