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 →
On October 13, Massimo Zaninelli held the lecture Introduction to EMA Clinical Trial Information System (CTIS) at the two-year Master on Regulatory Discipline “G. Benzi” – University of Pavia. CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and supports the flow of information between clinical trial… read more →
We are pleased to announce that Dompé S.p.A. has entrusted Maxer Consulting with implementing the Clinical Trial Disclosure (CTD) programme and consulting to implement the EMA Clinical Trial Information System (CTIS) in its organization for 2022. CTD’s activities require Maxer to ensure compliance by Dompé with the regulations in force… read more →
The conduct and oversight of clinical trials in the EU will undergo a radical transformation when the new Clinical Trial Information System (CTIS) goes live on January 31st, paving the way for the long-awaited Clinical Trial Regulation (No 536/2014) to take effect. The default setting in CTIS is to make… read more →
We are pleased to announce that the Zambon Group has entrusted Maxer Consulting to implement the Clinical Trial Disclosure program for 2021. The program requires Maxer to carry out the necessary activities to ensure Zambon’s compliance with the regulations in force in the European Union (EU Reg. 536/2014) and the United… read more →
FDA issued a press release on April 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance was sent to Acceleron Pharma ”… for failing to submit required summary results information to ClinicalTrials.gov.” The press release further states “……The Notice of Noncompliance… read more →
We gladly receive and publish the article by Robert Paarlberg on the issuing of the FDA final guidance on the Civil Money Penalties relating to ClinicalTrials.gov. On August 14th FDA issued a final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. The guidance finalizes the draft guidance dated September 21, 2018. The Federal Register notice announcing… read more →
At the EMA Management Board June 11th meeting, the Board endorsed the methodology and next steps to develop further the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation ‘go-live’ plan. A group including representatives of the Member States, sponsors, as well as representatives from EMA and the… read more →
