Pharmacovigilance Outsourcing: | > Overview and Benefits | Services Offered |

The Complete Outsourced Pharmacovigilance Solution

Assured Information Systems offer fully outsourced pharmacovigilance services whatever the client's requirements. We can support all pharmacovigilance tasks for single or multiple products through to assuming full responsibility for the entire global safety obligations of the company.

Outsourcing

Assured Information Systems has successfully provided fully outsourced pharmacovigilance services to the pharmaceutical industry in the US and Europe. Offering significant time and cost savings in clinical development utilising a combination of project management expertise, drug development know-how, underpinned by proven electronic trial management tools.

These services leverage the software and process capabilities of Assured Information Systems to deliver an integrated solution to pharmaceutical organisations wishing to outsource all or parts of their drug safety requirements - from the single product to an entire portfolio.

Business Benefits of Outsourcing:

• Meeting pharmacovigilance requirements needs trained individuals to code and clinically assess cases.
• Safety teams need to keep abreast of regulatory requirements at regional, national and international levels.
• Workload will have peaks and troughs, particularly with marketed products that are taken seasonally.
• Outsourcing allows you to focus attention where it is needed most i.e. a proactive, not reactive approach that ensures drug performance and overall safety. You gain access to specific expertise and place responsibility upon the supplier to meet the cost of items such as coding dictionaries.
• Regulatory Authorities are becoming more sophisticated. Current initiatives include electronic reporting, MedDRA coding and reporting and 21 CFR Part 11 compliance.
• These pressures are felt more keenly in companies with low case volumes who are unable to justify a full time pharmacovigilance specialist.

Software licenses and system operation can be expensive:

• System maintenance, management and validation are expensive non-core activities for a pharmacovigilance department.
• IT/IS support staff in many small and medium-sized companies are either unable or under significant pressure to provide complete service to their users.

In a nutshell - let the outsourced provider bear the cost of the initial license, software upgrades, system management and the management of all your product safety reporting requirements.

People, Process and Technology

A successful pharmacovigilance service recognises the need to integrate staff experienced in drug safety with an effective process. Through this, drug safety cases can be managed from the point of collection to regulatory reporting, underpinned by an effective electronic system to both manage individual cases and collate, analyse and generate signals and reports that alert the manufacturer to potential safety issues.

The service must operate within tight legal timeframes and agreed quality and audit standards whilst delivering against the expectations of all users be they within the pharmaceutical company, medical professionals or regulatory authorities.

Assured Information Systems have designed their solution to ensure that these three cornerstones of successful pharmacovigilance can be met in a cost-effective way.

Process

We offer a unique process founded upon the workflow management capability of our pharmacovigilance system. Working to our own or client's SOPs we utilise the PV-Works software to ensure compliance with specific requirements and adherence to reporting timeframes.

Poor communication between the system provider and the client has often blighted the successful implementation of outsourced pharmacovigilance in the past. We have solved this problem by ensuring clients' system access and a 'watching brief' over all our activities. This allows the process to be flexible – the client can be as "hands-on" or "hands-off" as they choose.

Next: Assured Outsourcing Services

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