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Ability to work across cultural, language and timeline barriers sets benchmark and achieves record patient recruitment in China despite pandemic.
Situation
A Canadian CRO conducting a global and important Phase III early breast cancer trial for a major pharmaceutical company engaged George Clinical as its partner for the Chinese portion of the trial. Globally, the study covered more than 400 sites in 20 countries and has currently enrolled more than 5,000 patients.
For the 15 sites in China, George Clinical was selected due to our extensive experience as the leading Asia-Pacific CRO. China is one of George Clinical’s largest hubs, outside the head office of Sydney, offering end-to-end CRO services and a site network that spans the country. We have been conducting clinical trials in China since 2007 with a network of over 300 trial centers in 60 cities for Phase II-IV trials, and a wider network that includes community health centers in semi-urban and rural areas for Phase IV trials.
Challenges
This study required a rapid startup while partnering with a Canadian company that was not familiar with Chinese regulations, requirements, practices and culture. The George Clinical team needed to help manage expectations and create a level of comfort during the initial stages of knowledge transfer based on our China experience.