The New Frontier

Charles Arnold and Vicki Tauscher Phelan of EquaTerra examine the burgeoning trend of outsourcing pharmacovigilance and clinical data management

As companies in the pharmaceutical industry continue their drive to reduce costs and enhance efficiency by outsourcing various processes, they are increasingly pursuing newer areas, specifically pharmacovigilance and clinical data management. Compelled by both external market factors and internal pressures to constrain costs and enhance shareholder value, pharmaceutical firms are turning to these two areas as they seek ways to maximise the resources devoted to their core activities – R&D and getting drugs to market. By shifting pharmacovigilance and clinical data management work abroad, they can help achieve this goal.

In what may be one of the first significant management outsourcing deals of this type in the industry, Bristol-Myers Squibb have made an agreement with Accenture for work being done in India.

Both pharmacovigilance and clinical data management are expensive operations, yet because they are process-driven, they are strong candidates for alternative delivery models. The work involves highly-skilled individuals, from registered nurses to specialist doctors, who are performing relatively clerical functions such as sifting through data and probing case reports; but despite the clerical nature of the work, it requires such a high level of expertise that a company must pay dearly for it if they want it done domestically.

The requirements – and therefore the stakes – of this kind of work continue to rise. Each new drug is put under great scrutiny and this is exacerbated by negative news coverage. The volume of events to be reviewed and addressed is going up at an incredible rate, and of course so is the cost.

BUSINESS PROCESS OUTSOURCING VERSUS CONTRACT RESEARCH ORGANISATIONS

Pharmacovigilance is a relatively new function in terms of outsourcing, and therefore there are not yet a significant number of providers currently able to perform this kind of work. Essentially, there are two classes of providers capable of moving strategically, and quickly, into this area:

• Traditional contract research organisations (CROs), who are focused on drug development and managing trials through their various steps and processes. These companies (such as Quintiles, Covance and MDS Pharma Services) are well equipped to step up and address pharmacovigilance. From a staffing perspective, they have the right ingredients, with doctors who are focused on the relevant processes.
• The more traditional business process outsourcing (BPO) organisations, particularly those based entirely in India (examples are Cognizant, Tata Consultancy Services, Infosys and Keane).