“The primary driver for the need of pharmacoepidemiology is increased enforcement by regulators worldwide to generate pharmacovigilance real-world evidence,” Dr. Jan Petracek, COO and CEO of PrimeVigilance.
“This is closely linked with pharmacovigilance planning and risk management, which have now entered in a new phase of maturity,” he told us.
“As a result, the vast majority of new products, and almost always when an important safety concern is identified, post-authorization safety and/or efficacy studies are requested by the regulator.”
Following the acquisition, PrimeVigilance, Ergomed’s pharmacovigilance subsidiary, will now be able to provide a full service in these areas.
The company also has hired Dr. Michael Forstner. “Dr Forstner’s role will be the Head of Pharmacoepidemiology and Risk Management, establishing a new revenue stream for Ergomed,” said Petracek.
In October last year, Ergomed bolstered its orphan drug development services with the acquisition of PSR Group BV in a deal that was worth up to $6.69m.