Wednesday, 12 August 2020

Consistent clinical trial quality is key for China

05 September 2013 | Opinion | By BioSpectrum Bureau

China continues to offer greater opportunities for outsourcing as the sponsor companies' look to off- load research and development spending.

China continues to offer greater opportunities for outsourcing as the sponsor companies' look to off- load research and development spending.


China's pharmaceutical market has grown steadily in the last few years and is projected to grow by an average 19 percent year-on-year over the next few years, according to Economic Intelligence Unit Report, Emerging China, July 2012. Significant investment by large global pharmaceutical companies has followed this growth along with the growth of the local Chinese pharmaceutical companies.

China continues to offer greater opportunities for outsourcing as the sponsor companies' look to off- load research and development spending. With the increasing numbers of clinical trials taking place in greater China, there has been an upturn in the employment of qualified and experienced clinical research staff. However, with a population of 1.3 billion, only a small number of households is becoming progressively affluent. More customers are now emerging at a slow but sure rate, making greater China a cash cow. Never-the-less, besides the biopharma sales market, patient recruitment is entirely achievable. The challenges lie largely in keeping the quality of clinical trial consistent to produce efficacy data for regulatory approval.

Executives from the top 20 biopharmaceutical companies say that the biggest challenges are the regulatory barriers, such as approval taking on average up to five years, protection of intellectual property, and sourcing reliable distribution partners. Other key challenges include the difficulties in sourcing senior and junior talent. On one hand there are more opportunities for outsourcing companies to demonstrate a level of quality to their clients in the ever evolving landscape. On the other hand, the global biotech industry and their need for clinical trials to be completed in time, cost effectively and in large numbers in order for international companies to launch products in the region.

The demand for clinical outsourcing is constantly on the rise. For companies to overcome these hurdles, flexible recruitment solutions are needed by clients more so now than ever before. To cope with the need for clinical trial management, monitoring and quality auditing as a short-term solution, freelancers, consultants and partnerships are more frequently engaged. This, however, does not always meet the long-term requirements of companies, who will need to employ people in these roles. Although the industry is growing and requires new qualified staff, the local talent pool is not increasing at a fast enough rate, thus leaving companies struggling to train entry level candidates and looking for alternative solutions.

Bringing in talent from outside the local area is not a viable solution as local experience is required to effectively conduct the monitoring of clinical trials. This leaves companies competing for candidates in the local talent pool. This is driving up remuneration packages and in turn creating a candidate strong recruitment market. Identifying talent is only part of the work. What companies always find challenging is attracting the talent. Traditionally, as a recruiter, the best recruitment process involves an ongoing relationship between a recruiter and hiring manager. The common approach, which is being adopted by many of the big CROs and corporate biopharmaceutical companies, involves moving away from this traditional and very effective way of working as they establish talent acquisition arms to their HR function in order to take on their growing demand for headcount.

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