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 →
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 →
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 →
Massimo Zaninelli, Maxer Consulting CEO, has published on PharmaStar the article Clinical Trial Disclosure and Data Transparency: an obligation or opportunity? The publication of interventional clinical studies is mandatory both in the European Union and in the USA. The author intends to highlight the benefits that this activity offers to the… read more →
Clinerion’s Patient Network Explorer will leverage Maxer’s extended network of relations in the international healthcare sector to access promising business opportunities and expand Clinerion’s patient coverage into Italy, promoting and delivering clinical trials-related solutions. Clinerion and Maxer will cooperate to engage clinical trial sponsors to fully exploit Patient Network Explorer’s… read more →
The April issue of the Government & Policy Update dedicates ample room to the impact of COVID-19 on the management of clinical trials. Among the other principal topics, the latest monthly GPU deals with: Real-World Evidence EU/Brexit Clinical Trials Clinical Trial Disclosure Drug Development Gene Therapy Pricing Drug Quality Drug… read more →
Maxer Consulting (Italy), in collaboration with Paarlberg and Associates (US), is pleased to present the monthly Government & Policy Update (G&PU). The G&PU encompasses the most relevant updates in drug development, regulatory affairs, clinical trial disclosure, medical marketing, health technology assessment, pharmacovigilance, and other key topics in the ever-changing international pharmaceutical landscape.… read more →
We gladly receive and publish the article by Robert Paarlberg on the recent ruling which envisages a new interpretation regarding the publication obligations of clinical trials prior to 2017 on ClinicalTrials.gov. On February 24th a New York federal judge ruled on a case related to the FDAAA Final Rule stating… read more →
Maxer Consulting took part in the DIA Europe 2019, one of the major events dedicated to the professional update in clinical research. The debate focused on many issues, among which it is worth mentioning: Patient centricity: with a touching witness Dave de Bronckart, Member of British Medical Journal Patient Advisory… read more →
“During this eDM DIA 2018 Forum, it became very clear that Machine Learning is able to gain knowledge out of information, much faster than humans– commented Hans van Bruggen, CEO & Regulatory Affairs Scientist of eCTD consultancy and member of the Program Committee. It was also proven that Robotic Process… read more →
