PV-Works: Easy to Use Drug Safety Systems

PV-Works is Assured’s comprehensive range of regulatory compliant drug safety software for both the human and veterinary industries. In addition to adverse events, PV-Works also handles inquiries and product defects. PV-Works includes everything you need for electronic reporting, querying and trending.

PV-Works is used by large global enterprises as well as small local companies – Pharmaceuticals, Biotechnology, Generics Manufacturers, Pesticides, CROs, Regulatory Authorities, etc.

Complete E-Reporting with PV-Works

PV-Works provides a complete electronic reporting solution for the submission of safety data to the FDA, EMEA and other regulatory authorities worldwide.

Fully compliant with the ICH E2B and the EMEA’s EUVeterinary2.2 schema.

PV-Works is being extended to include the FDA’s HL7 format.

Human Pharmacovigilance Software

Paper-based regulatory reports, FDA3500 (MedWatch), CIOMS, etc.
MedDRA coding
Management control of deadlines and SOP’s via integrated workflow engine
PSUR Generation
Clinical Trials and marketed products

Veterinary Pharmacovigilance Software

Paper-based regulatory reports, FDA1932, CVMP, etc.
VedDRA coding
Management control of deadlines and SOP’s via integrated workflow engine
PSUR Generation

Outsourced Pharmacovigilance

Some companies need support with the IT infrastructure around their safety database.

Is this solution appropriate for you? Why not discuss it with us?

Outsourced Pharmacovigilance

Dedicated database
Managed in our secure data centre
You focus on product safety

For those with simpler requirements or who are uncertain of their immediate needs, why not try PV-247? You won't even have to talk to us ...

Please contact us to discuss your requirements and arrange a demonstration

Assured Information Systems Ltd, 5 Eaton Court Road, Colmworth Business Park, Eaton Socon, St Neots, PE19 8ER, England.
Telephone +44 (0) 1480 212223 Fax: +44 (0) 1480 216495