PcVmanager
One solution for all of your Pharmacovigilance Management needs
PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports.
PcVmanager helps you manage the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs via our integrated E2B gateway, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation. A variety of other regions is supported through different report formats, like MedWatch or CIOMS.
Intuitive user interface: supporting all aspects of pharmacovigliance management
Many options for submitting reports
Once an Adverse Event report has been created, verified and validated you can submit it to an agency and/or business partners via the following methods:
- E2B compliant gateway (EudraVigilance gateway)
- XML creation and manual import to EVPOST
- E-Mail system as an XML-file or document attachment (e.g. reports)
- Paper based reports (electronically and/or printed, e.g. CIOMS I)
PcVmanager utilizes a client/server architecture allowing multiple users to access one AE report simultaneously. Case reports can be reviewed at different sites and imported on a central site via a corporate network based on the E2B specification.
Functional Overview and Concept
PcVmanager is fully compliant with the regulations, directives and the general guidance related to electronic reporting of an Adverse Event and is 21 CFR part 11 compliant. PcVmanager capabilities include the following:
- Adverse Event Management that includes:
- Availability of all E2B specified fields and customer specific attributes
- Integrated MedDRA browser
- Case validation based on EMA business rules
- Versioning of cases for follow-up information
- Additional attachments for cases like CIOMS I, MedWatch, email, etc.
- Integrated submission management for direct submissions:
- To the EudraVigilance Post-Authorization Module (EVPM)
- To the EudraVigilance Clinical Trial Module (EVCTM)
- To NCAs and global trading partners via gateway
- To a specific email address or a list of email contact
- Complex search functionality which allows specific grouping, filtering and administration of search results
- Support for CIOMS I, Line Listings, Tabulated Summaries, as well as MedWatch reports and configurable reports etc.
- Simplified Signal Detection
- Integrated workflow engine and task view
- Easy E2B-compliant XML file import and export
- Fully Scalable
On request PcVmanager can also easily be integrated into state of the art document management systems such as
- CSC FirstDoc™, CSC FirstPoint™
- EMC Documentum™
- IBM SCORE™
- MasterControl™
- Microsoft SharePoint 2007 and 2010™
- NextDocs™
- OpenText™
- Optimal Systems™
- QUMAS DocCompliance™
or others and connected to company specific databases.
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PcVmanager in the Cloud
PcVmanager is also available as a hosted / software-as-a-service (SaaS) solution.
Available Modules
DMSconnect
Integration with leading document management systems
Multi Tenancy Module
Allows managing and data separation for several customers
Gateway
Automatic transmission and reception of E2B compliant XML-files to and from EMA and NCAs
Customer Quote
“With the huge amount of products Genericon has to handle a flexible and strong reporting capability was one of the main requirements for the solution we were looking for. PcVmanager allows us to build a strong knowledge base fulfilling all legal requirements and reaching the highest level of product safety for our customers.”
Dr. Rainer Maue
Director Business Development, Technical Operations and International Business of Genericon