The development and management of a pharmacovigilance system is a procedure required in the context of every clinical trial to ensure the patient’s/participant’s safety. Therefore, it is very important to have the necessary resources and optimized processes, as well as an effective planning to ensure the appropriate completion and management of the activities required in pharmacovigilance.
It is necessary to have knowledge of the European and international legislation that allows to develop these activities beyond national borders (Reporting to EudraVigilance) to have ongoing studies in which safety information is managed in different countries.
Experior has a highly qualified professional team with this training and large experience that provides the service required for the interpretation, coding and reporting of any serious adverse event or relevant safety information, ensuring a management adapted to the project based on the current legislation and the established deadlines.
Active studies with global sites distribution
DSURs (development safety update report) drafted and reported.
The pharmacovigilance professional team of Experior has the ability to offer to their clients a number of services, during the clinical research phase and the post-marketing phase:
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