Analyzing Application of Offshoring

Offshoring Country selection: China China, undeniably, represents one of the best markets to perform a clinical trial. It is home to the largest global urban population, and provides an extensive patient pool as well as a vast network of hospitals. The country boasts of nearly 1.4 million physicians/doctors and over 1 million technicians and nurses. Low medical staff salaries partly contribute to lowering clinical trial costs in China by around 50% of the cost in America.

Pharmaceutical firms find China an attractive option; it is projected by some that, by the year 2020, China might overtake America as the largest global market (CDE and CFDA, 2013). The nation is quickly being recognized as an attractive location for carrying out clinical trials by providing sponsors with multiple benefits, some of which are: 1) China is the most populous Asian country; and 2) It can provide pharmaceutical companies with a large share of subjects diagnosed with major diseases, that are of interest to pharmaceutical firms.

Other advantages include: highly skilled investigators, strong infrastructure, low costs, superior patient recruitment as well as adherence rates, and firm ethical support (Puppalwar, Mourya, Kadhe & Mane, 2015). One fact to be noted is that delay in regulatory timelines offers unique advantage to trials carried out in China: investigators normally devote this additional time to improving the process of selection, thereby warranting quick recruitment of patients, with rates that are ahead of targets.

Benefits For encouraging an increasing number of foreign firms to come to China and perform their clinical trials, the Chinese government has enacted fresh rules and has been instituting clinical practice facilities for training staff and investigators. While only CFDA (China Food and Drug Administration)-designated health centers are authorized to conduct trials, such institutions' principal investigators typically have broad experience working with Western firms, thus making the process smoother (Soni & Singh, 2013).

The regulatory process of China is an effectively -controlled and documented process conducted strictly in accordance with regional regulations, ICH (International Conference on Harmonization), and GCP (good clinical practice). In an effort towards revitalization, the Chinese regulatory body renamed itself, in 2013, as the CFDA. Its operations are similar to that of the American FDA, and it tasks the CDE (Center for Drug Evaluation) with reviewing clinical trial applications (CDE and CFDA, 2013).

Of late, China has grown into a key location for clinical trials, as it is characterized by an exceptional combination of a huge population (more than 1.4 million individuals) and low costs. China's population is both genetically diverse when compared to Western countries, and is afflicted with a vast pool of diverse chronic and acute illnesses. The country can offer substantial cost savings when compared to Western nations, in the performance of clinical trials.

Phase I clinical trials are roughly 50% cheaper in China than in the West, whereas Phase II & III trials are 60% cheaper (Soni & Singh, 2013). Additionally, China is characterized by high rates of patient enrolment, facilitating fast completion of clinical trials and ensuring companies can enjoy patent exclusivity benefits for longer. Other factors that make China an attractive option are: availability of first-rate research and clinical manpower well-versed in English, expertise in different therapeutic areas, enhanced protection of intellectual property, and advanced IT infrastructure.

The nation offers a growing market and vast population. Chinese scientists' expertise and capabilities are level with highest global standards. Chinese clinical trial information is accepted by peer-reviewed journals and at major international conferences. Also, English is used as the primary research and education language. Lastly, strong general economic growth will assuredly result in improvements to China's healthcare infrastructure (CDE and CFDA, 2013). Challenges In spite of all the aforementioned advantages, China poses some challenges as well when it comes to performance of clinical trials.

Bureaucracy and stringent governmental regulations pose continuous risks for firms. For instance, gaining CFDA approval for conducting a trial may take anywhere between 9 and 12 months. Further, firms need to acquire drug import licenses for all shipments entering the nation, instead of one for every drug type. China's national infrastructure is weak and intellectual property rights in the nation are irregularly enforced. Language and cultural differences add to costs, and may hamper the clinical trial process.

For instance, Chinese researchers continue recording data in their native language, which increases translation costs and further delays the process (Puppalwar et al., 2015). Weak measures for protecting intellectual property, coupled with clinical trial taxes and other forms of Chinese governmental intervention are major barriers.