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.

One problem with smaller, dedicated pharmacovigilance consultancies is that they won’t have the facilities to provide safety databases and expedited reporting but there are a few who can offer it, mainly through arrangements with third parties who will perform these functions on the consultant’s behalf. Amongst these consultancies the depth and range of expertise will vary widely. Some consultancies, for example the UK-based Elliot Brown Consulting, will have medically trained staff and will involve a global network of pharmacovigilance associates including former senior regulators and industry specialists. Pietrek Associates operate in a similar way. Companies such as these can often provide high end consulting, helping to deal with serious safety issues that can affect pharmaceutical products, in addition to the more run-of-the-mill pharmacovigilance activities which would include writing and review of PSURs and auditing. With such companies the costs of these consultants can seem high but it must be borne in mind that they can often turn work around faster. More experienced contractors may be able to complete a project faster than their less experienced counterparts thanks to their greater experience and knowledge.