Updated on 13 April 2012
Outsourcing to CROs in Asia needs strategic planning
The conventional view of contract research organizations (CROs) bears little relationship with the way in which they were perceived ten years ago. Traditionally, the CROs provided support to pharmaceutical and biotechnology industries in the form of research services on a contract basis. The advantage for the drug sponsor was that they did not have to maintain staff as they moved new drugs or devices from conception to marketing approval.
In 2010, the pharmaceutical sector had the dubious honor of topping all others when it came to job losses. In a single year, pharmaceutical companies cut approximately 54,000 jobs in the US alone and another 28,000 jobs disappeared from the healthcare sector. After this, strategy planning in addition to biometrics, laboratory studies and clinical trials too had to be outsourced.
The large global CROs have matured from their traditional role as body shops for resources and service providers to become specialists in clinical development. Their activities cover all phases of development, data management and study design expertise. As market pressures dictate an accelerated development process, timetables must be reduced with no room for wasted studies. These goals can only be achieved when the pharma and the biotech industries partner with the CROs early in the development process and engage in collaborations rather than employing CROs as though they were hewers of wood and bearers of water.
Sponsors may of course transfer any of their trial-related duties to a CRO, but the ultimate responsibility for quality and integrity of trial data remains with the sponsor. The sponsor ensures that the CRO has on board quality assurance and quality control. Accordingly, the selection of a CRO partner is critical to the ultimate success of any outsourced strategy.
There are currently 1,100 CROs in the world, the size of the market having exceeded $24 billion in 2010. While the revenues are growing year-by-year, the number of CROs is likely to shrink, largely as a result of a continued trend towards consolidation. They range in size from large international full-service organizations with over 20,000 employees, to niche specialty groups, providing clinical trial services to universities and research bodies, government organizations such as National Institute of Health and traditional sponsors from the private sector.
The pharmaceutical giants have long recognized that up to 70 percent of studies fail to recruit to target and 30 percent of sites fail to recruit a single patient. The CROs have the ability to improve this unfortunate situation by engaging the sites in a collaborative effort, having a genuine global footprint and integrating recruitment and retention delivery systems. In the partnership between a CRO and a sponsor, the latter pays a fee for service and, in an ideal situation, the partnership agrees upon risk-sharing milestones. Once the partnership is established, clinical trial performance improvement leads to reduced time in drug development and optimized analysis of trial results. However, unless the fundamental strategy is right and has taken into consideration regional imperatives, the added value of time-saving is lost. This is especially true in Asia, where the opportunity is matched by the complexity of an ever-evolving regulatory and infrastructure landscape.