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.