Hosted Pharmacovigilance Services

For many companies the technical requirements of operating and supporting a regulatory compliant pharmacovigilance computer system exceeds the skills of the internal IT team.

Assured can manage PV-Works for you. Via a hosted solution, where the hardware and software is installed in Assured's facilities, you can connect remotely to input, review, approve and report your pharmacovigilance data without having to worry about system administration tasks.

Assured will set up a PV-Works database on our server:

Provision of internet access to the server for use of PV-Works by each client
Installation and set up of the client database
Regular back up of the client database
On-going configuration and change management of the hosted system
Operation of the system in accordance with GxP
Installation of new versions of PV-Works at the client's request

The client will retain responsibility for:

Formal validation of PV-Works
All case processing – from initial receipt to reporting to the regulatory authorities and other interested parties

The Assured Citrix Metaframe server:

Assured uses Citrix Metaframe extensively in its office and for its hosted Internet-based pharmacovigilance service. We also recommend this route for most medium and large sized customers who implement PV-Works in-house.

Clients using the Hosted Service will access the server via secure Internet connection.

As for customers who license PV-Works for use in-house, our full Help Desk service is available to ‘Hosted’ customers.

Training

There is still a need for users to be trained to use PV-Works, but only as 'end-users' and not as 'administrators'. This training is available via Assured.

Upgrades

At any time, a client can migrate from a hosted service to an in-house installation of PV-Works. The software used for the hosted service is identical to that installed on a customer site.

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