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Even with the rapid increase in clinical trials and demand for cloud-based systems, doing business in China is not easy if you are unfamiliar with the territory.
The recent article by Paul Donnelly of the Australian-based CRO George Clinical confirms what the industry is saying about the current and future states of the clinical research market – especially as it relates to EDC adoption – in China.
We agree with his review. So much so, we’d like to add our own observations, born out of direct experience in China.
In a white paper published earlier this year, “China on the Rise: Growing Clinical Research Sector Offers Multiple Opportunities,” we identified a number of factors that support the ascent of the Chinese clinical research market to world-class status.
First and foremost, the Chinese government is serious about this market. In recent years it streamlined the clinical research approval process. Government policies now focus more support on strengthening China’s healthcare infrastructure and R&D. In 2013, the government took a major step forward when it reorganized and elevated the China Food and Drug Administration to a ministerial-level agency.
Then there’s tech. China is witnessing rapid adoption of – and investment in – digital technologies, fueling greater connection and access to patient populations. In 2014, more than $141 billion were invested in technology products and services, including cloud and SaaS (Software-as-a-Service) models.
Back in 2007, the China Internet Network Information Center estimated that about five million Chinese citizens owned smartphones. In 2013, that number had mushroomed to more than 700 million. It’s no surprise that China is now the world’s largest smartphone market by volume.
Finally, China is aging. It’s projected that more than 10% of the population will be age 65 and older by 2020, and there will be 223 million people over age 65 in China by 2030. With their associated increasing medical needs, these individuals will significantly affect the Chinese healthcare sector, especially drug and medical device development.
Adding it all up, China’s ascent is, well, staggering. In just five short years from now, China is expected to become the world’s second largest drug market, after only the U.S., and spending on pharmaceuticals is expected to reach $107 billion this year (4x since 2007). Like everywhere else in the world, EDC adoption rates are on the rise in China, and the cloud-computing market across the country is projected to increase by 45 percent in 2015.
Know before you go
Now, lest you think China will embrace you and your solution with open arms no matter what, let’s present a balanced picture.
Even with the rapid increase in clinical trials and demand for cloud-based systems, doing business in China is not easy if you are unfamiliar with the territory. In fact, the requirements for foreign-based companies to operate effectively there are more demanding than in most developed countries. Their regulatory system is generally risk averse; the available talent pool, while good and getting better, still needs intensive training in clinical research and EDC operations; and a healthy pipeline of effective compounds is still developing.
Based on our experience in the Chinese market, though, there are a number of steps software providers can take to increase their odds of success.
First and foremost, think Chinese. While nearly one in every five Chinese citizens is learning English, your solution needs to supports the Chinese language(s). Have your software render in Chinese, make sure technical documentation and collateral materials are in Chinese, and have your support team members speak the language fluently. And be sensitive to the region in which you operate; dialects across the country differ greatly.
Second, “pretty and practical” count. Be certain your platform’s design, user interface and capabilities are attractive and easy to use. Superior randomization, dispensing and medical coding functionalities won’t account for much if using them is not intuitive.
Finally, be there. A visible and meaningful presence with staff that can provide comprehensive support and training are imperative. And make sure employees across your organization learn and adhere to local business customs and cultural nuances. (Earlier this year, we produced an eGuide on this topic that might prove helpful: Five Proven Ways to Gain Cultural Confidence in China’s Life Science Market.)
EDC system access and training will help smooth China’s inevitable global clinical research industry leadership role. While that’s certainly good news for researchers, sponsors, CROs and EDC providers, it’s even better news to millions of patients worldwide. They’re the ones who will eventually benefit the most.
Simon Hawken is Vice President, International Sales for Merge Healthcare/eClinical Division.