Extedo upgrades PcVmanager drug safety software
30 June 2010
Extedo, a key eRegulatory Affairs solutions provider for life sciences firms, has announced the availability of PcVmanager 1.3, a major new release of the leading drug safety software management solution based on E2B and MedDRA standards.
PcVmanager enables users to classify, create, review, submit, and maintain Pharmacovigilance data and adverse reports. The product manages the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.
PcVmanager version 1.3 contains the following new features and enhancements:
Key benefits that firms will derive from the integrated solution are — reduced time to market, increased collaboration between different departments, and improved compliance with regulatory requirements.