Outsourced Pharmacovigilance Services

Let us manage the IT while you focus on pharmacovigilance.

Assured will host your PV-Works database in a secure server environment leaving you to manage the safety data

Why Outsource?

The need for marketing authorisation holders and clinical trial sponsors to comply with regulation of adverse events is a critical success factor. However, for many companies the technical requirements of operating and supporting a regulatory compliant pharmacovigilance computer system can be both relatively expensive and exceed the skills of the internal IT team.

Assured has addressed this by offering hosted services for the human and veterinary pharmaceutical industries since 2004:

• The PV-Works software suite is deployed in a sophisticated data centre with 24/7 monitoring
• Secure internet access to the system for customers from anywhere
• Full PV-Works functionality. No additional modules required
• Each customer has its own dedicated database
• EDI gateway provided to automate electronic reporting
• Assured takes care of the IT aspects, including offsite back-ups, upgrades and the electronic reporting gateway

Benefits

Managed services are the obvious implementation option for many companies, particularly those in the SME sector. The need to comply with regulation that is making increasing use of IT solutions (e.g. electronic reporting) places a technical demand on companies that can be addressed most cost effectively and reliably with a partial outsourced hosted model.

There are other benefits that accrue from this option that may be valued by a wider range of companies:

• Off-site hosting is typically less expensive than an in-house installation
• Outsourcing does not require the large "first year" cost normally associated with an in-house system
• Outsourcing delivers an immediate, secure, multi-location pharmacovigilance network with minimal IT investment
• Access is possible from any internet connection in the world (including home offices and hotels) yet offers the same secure connection at all times
• Full functionality of PV-Works is available at all times:
• E-reporting capability
• Report / PSUR Generation
• Regulatory compliance
• While the IT element is outsourced, the hosting model still leaves you in charge of the safety data and reporting

The Off-Site Environment

The PV-Works hosted servers are located in a 'state-of-the-art' Secure Data Centre where all critical equipment is duplicated and provision is made for 24/7 monitoring and automated recovery. In particular the centre offers:

• Dual power supply with UPS and back up generators for emergency use
• Air handling and fire protection
• Physical security includes 3 metre high fencing and electronic door entry systems
• Logical security includes firewalls and anti-virus checks
• Raid-1 duplicated storage of all database data (and application software) on separate disks
• Daily back up of database with off-site storage both on a separate server and on tape
• A redundant server in the Data Centre is available for recovery from a catastrophic failure of the primary server

Assured Training and Support

As part of the Managed Service, Assured will

• Install and configure the customer's safety database to an agreed specificatio
• Train users
• Back-up each customer's database every night with automated off-site storage
• Perform on-going configuration and change management of the managed system including regular MedDRA / VedDRA upgrades
• Install new versions of PV-Works at the client's request

In order to comply with all regulations the PV-Works application requires validation. This task is reduced with the Managed Service and Assured can expedite it further with the use of standardized validation plans which we can help customers modify for local needs and can assist with the execution.

Upgrades:

A client can migrate from a hosted service to an in-house installation of PV-Works at any time (and vice-versa). The software used for the hosted service is identical to that installed on a customer site.