It costs money to recruit staff and keep them permanently. It costs a LOT of money to set up a pharmacovigilance system. For example a full working drug safety database on its own can cost in excess of £200,000 before the staff to run it are even notified of vacancies.

2.) PROVIDING FLEXIBILITY

A lot of companies strike a balance between permanent staff and hired hands by bringing in consultants to provide flexibility during periods of higher workloads. This enables them to meet their regulatory requirements while at the same time ensuring that there isn’t an excess of staff during quieter times.

3.) COVERING FOR OTHERS

Sickness, maternity leave and all sorts of other factors can leave temporary gaps in the workforce. Just because employees are not present doesn’t mean the work goes away and inevitably it may be necessary to bring in temporary cover for absent colleagues.

4.) PROVIDING EXPERTISE

From time to time specific, highly specialized, expensive skills are required to carry out pharmacovigilance effectively. Those who can do the work may then not be needed for a period of time before they are next required, if they are required at all. Rather than having pharmacovigilance experts sitting around twiddling their thumbs and drawing a wage, it can make a lot more sense to temporarily draft in help when needed in order to gain their support and expertise that is not currently available in-house.

Almost all of the functions and work of a pharmacovigilance department can be outsourced effectively. This includes both the work for clinical trials and post-marketing spontaneous adverse event reporting.

However if a client wished to outsource the majority of their pharmacovigilance activities – both the routine work and the one-off activities – contracting in would not be appropriate. Instead such a client would use a contract organisation or, in this case, a “PV service provider”. Some of these service providers will be the big CROs (Contract Research Organisations) – Parexel, Quintiles for example – whose main specialism is clinical research but who also do pharmacovigilance as well. Others will be the specialist pharmacovigilance service providers like PrimeVigilance Ltd, PharSafer, Vigilex who are equipped to run all the pharmacovigilance activities but do not engage in clinical trials. When

At the other extreme of the spectrum, the client may wish to outsource most of the pharmacovigilance activities, routine and non-routine, to a contract organisation (a “PV service provider”). These companies may be very large Contract Research Organisations (CROs) such as Quintiles or Parexel, that concentrate on clinical research, but carry out pharmacovigilance activities as well. There are also specialist PV service providers, such as PrimeVigilance Ltd, PharSafer and Vigilex, that carry out all pharmacovigilance activities but do not perform clinical trials.

In other cases the requirements are more finely grained. A client might need a more limited range of the routine work to be covered – activities such as the processing of individual cases, expediting reports to the regulatory authorities in accordance with their expedited reporting timescales and preparing PSURs – but may prefer other elements to remain either in-house or subject to their current practices. In such cases the cost of using one of the larger CROs might be prohibitive although they would certainly have the capacity to do the work. In cases such as this a dedicated pharmacovigilance provider might be able to deliver an approach that returns competitive cost-effectiveness without jeopardising quality. There are also several companies with bases in India that offer to perform some of this basic work. Such solutions may seem very competitive and costs may be far lower than any of their competition. However when something seems to be too good to be true, it may well be because it is. Firstly there may be concerns about how easy it would be to keep effective control of quality and of events from such great distances. Secondly there is the issue of knowledge and training – the pharmacovigilance requirements in India, such as they exist, are far removed from those in the West; India is still a developing nation and governments have higher priorities. Consequently in practice they tend not to legislate for any more than rudimentary medicine safety. Doctors trained in such an environment going in to a pharmacovigilance outsourcer might struggle to come to terms with the exacting nature of the regulatory environment in the West.