Ennov PV-Works (human)
Pharmacovigilance Software System
PV-Works (human) is used by many drug companies, CROs, and consultancies to record, report and analyze spontaneous and clinical trial adverse events. PV-Works (human) meets all international regulatory requirements, including ICH E2B electronic submission, and can be implemented as a cloud based solution (see www.pv247.com) or on-site.
General Software Description
PV-Works (human) is a flexible software system designed to support pharmacovigilance business processes and technical services case handling practices, whilst meeting the associated company safety and world-wide regulatory reporting requirements.
The pharmacovigilance database has been designed around the ICH E2B guideline such that every E2B data field maps to a specific database field. Coding to MedDRA is simple. In addition to paper reporting outputs such as CIOMS and MedWatch 3500s, an electronic reporting function is included. Aggregate listing outputs like PSUR, DSUR, and PBRER are simple to generate using built-in tools.
In addition to simple yet comprehensive data entry and reporting functions, the fully integrated workflow functionality will ensure SOP compliance and that critical reporting deadlines are met. Regulatory compliance is afforded with the adherence to key requirements such as FDA 21 CFR Part 11 and the provision of a full audit trail.
Benefits of PV-Works solution
- Industry standard – proven software used by many drug companies, CROs, and consultancies
- Validated solution – fulfill requirements of internal and external regulatory audit
- Ensure compliance – generate regulatory compliant outputs both in paper and electronic format
- Structured data collection – (including validation at the point of entry) to improve later trending and analysis
- Integrated solution – capable of handling pharmaceutical, biological, medical device, and cosmetic vigilance as well as managing product defects and technical enquiries
- Trending and analysis – powerful and flexible functionality built-in
Workflow Based Pharmacovigilance
PV-Works (human) is a process driven system. A purpose-built workflow engine is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.
Query Based Pharmacovigilance
PV-Works (human) includes a wide range of powerful querying functionality, allowing business teams to monitor case handling, track compliance, and execute in-depth trend analysis.
- Comprehensive data querying and powerful analysis
- Direct data export to Excel
- Management reports built-in
Available as cloud based solution – see www.pv247.com
On-site deployment scalable from single PC to corporate solution
Oracle database on Windows / UNIX / Linux servers
Compatible with Citrix, 2X, Windows RDP and other thin client middleware
Agile development methodology
Interface with Microsoft Office
Interface with Crystal Reports
Electronic Reporting with PV-Works
PV-Works (human) submits electronic adverse event reports in full compliance with the ICH E2B standard (both R2 and R3 formats are supported). Furthermore, electronic medical device adverse event reports may be submitted to FDA CDRH in eMDR format.
PV-Works (human) is easily integrated with standard AS2 gateway software to manage automated submissions. Acknowledgement messages and batch submissions are comprehensively handled.
The import of E2B compliant XML formats is also fully supported, allowing receipt of cases submitted to industry directly from Competent Authorities and partners.
- Query functionality: User-friendly query tools which make it easy to explore and understand your data
- Case approval concept: Straightforward case review and data approval concept, to ensure quality of regulatory output
- Flexible workflows: Easy to configure process flows that match existing business processes
- Customer support: Experienced and knowledgeable support team on-hand to help you get the best out of your implementation and configuration
- Collects and reports safety data to meet all common international regulations including ICH E2B
- Coding of cases against current MedDRA dictionary
- Extensive data validation, cross-field checks and use of pick lists
- Handles spontaneous and clinical trial adverse events, technical enquiries, and product complaints
- Duplicate check function
- Integrated spell-checker
- FDA 21 CFR Part 11 compliance
- Case data export
- Notes may be added to any field
- Full audit trail
- Letter generation
- Database may be used with third-party query and reporting tools
- Extensive use of reference dictionaries, e.g. contacts, laboratory tests
- Integrated document management
- Built-in query tool
- Handles user time zones in a global implementation
Cloud-based or On Site
Ennov PV provides a comprehensive solution to the management and reporting of human and veterinary adverse events.
Remote safety data capture.
PDF file or dynamic browser-based web form.
Web based pharmacovigilance case data entry.
Efficient and configurable web interface. Speech to text.
Complete pharmacovigilance database with configurable workflows and reporting.
Signal detection and analysis.
Out-of-the-box use by business users.
Broad array of statistics. Powerful data cubing and visualisation.
Why Choose Ennov ?
Complete pharmacovigilance solution
- Comprehensive features
- Intuitive case entry
- Validation workflows
- Reporting to authorities
- Advanced analysis
- Manage any product type
- Human drugs
- Pharmaceutical drugs
We respect your freedom of choice
- Available as cloud or on premise. You can switch between options at any time.
- If cloud based we offer single-tenancy to minimize version upgrade risks and validation upgrades. Data are hosted locally for total flexibility, improved security and optimized performance.