Pharmacovigilance und Vigilance Service
Pharmacovigilance, the monitoring of drug safety, is mandatory for sponsors of clinical
trials and for marketing authorisation holders or applicants for a marketing authorisation.
This is not only about the legally compliant handling of reports received about adverse drug
reactions, but in particular about the assessment of the risk-benefit profile of an active
substance or a medicinal product.
There are also mandatory vigilance tasks for medical devices.
SocraMetrics offers the one-stop shop around pharmacovigilance/vigilance for pharmaceutical companies. Our team, with its many years of inspection-proven experience, sets up and maintains pharmacovigilance systems and coordinates our clients' global project management. In doing so, SocraMetrics can either cover the entire obligations of the pharmaceutical company or only partial aspects - depending on the company structure.
We support companies from the very first step when it comes to planning a clinical trial, and our services cover all aspects of pharmacovigilance and thus the entire life cycle of the product: from the trial to the marketing authorisation and the regular marketing process.
Our highly qualified team also acts as the person responsible for pharmacovigilance for the pharmaceutical company (EU-QPPV, UK-QPPV, Graduated Plan Officer in Germany).