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

Technical

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.

Customers Love

• 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

Core-capabilities

• 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