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International Clinical Trials

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).

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Charles Arnold is Managing Director at EquaTerra, having spent his entire career in the business management of IT with a speciality in service delivery transformation. In the past three years Charles has facilitated nearly $1 billion in outsourcing contracts, primarily in the healthcare and pharmaceutical industry group. Prior to joining EquaTerra, Charles was a founder and Chief Operating Officer of InSource Partners Corp, acquired by EquaTerra in 2005, where he was responsible for all aspects of client delivery for a team of 50 advisors. This followed a period as Chief Technology Officer and a Principal with Fourth Floor Consulting. Prior to joining Fourth Floor, Charles held various account implementation and remediation positions at EDS. He was primarily involved in account transition, addressing issues related to account start-up or account team non-performance.

Vicki Tauscher Phelan works in the Life Sciences team for EquaTerra. She has more than 20 years of expertise in IT, consulting and outsourcing, with particular knowledge of the healthcare and pharmaceutical industries. Prior to EquaTerra, Vicki was Managing Director of aligne inc, an IT sourcing advisory firm, where she was the driving force behind the development of aligne’s successful healthcare outsourcing practice. Before aligne, Vicki spent nearly 15 years in IT, 12 of which were with IBM where she was responsible for partnering with senior-level executives in Fortune 100 corporations to develop their strategic information technology plans. Vicki holds a Master’s Degree from Duke University in Environmental Engineering, Law and Business and an undergraduate degree from Allegheny College in Environmental Science.

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Charles Arnold
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Vicki Tauscher Phelan
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