Maxer collaborates with the Chiesi Group for the EudraCT project

Maxer Consulting collaborates with the Chiesi Group in implementing the European Clinical Trials Database (EudraCT).

Through EUDRACT the European Medicines Agency (EMA) aims to collect and index the clinical trials conducted in European countries with the purpose to publish the documents related to drugs approved for human use and marketed in various European countries. Until now this information, which is an integral part of applications for marketing authorization for medicines for human use, was restricted to the European Agency. According to the same EMA, “…The Agency embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making […] on an application for a European Union (EU)-wide marketing authorisation (of drugs for human use)”.[1]

The project involves a careful analysis of data of numerous clinical trials, in order to publish on EUDRA CT the required and necessary information.