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:

  • Enhanced user interface that highlights mandatory entry fields and supports E2B specification titles More flexible management of attributes Improved search functionality New workflow enhancements Support for case type changes Addition of new reports for QPPV and Simplified Signal Detection
  • EXTEDO, a Microsoft Gold Partner, will also be demonstrating the integration of their eCTDmanager Suite with the Microsoft SharePoint 2010 business collaboration platform.
  • The seamless integration of Microsoft SharePoint 2010 and EXTEDO eCTDmanager Suite helps life sciences firms manage the entire lifecycle of their regulatory documents. With the integrated solution life sciences firms can view, review, compile, and publish information by using the standard SharePoint 2010 interface at the DIA Annual Meeting.

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.

To top