Genzyme China: 3 Top Tips for Effective Clinical Operations
With more clinical trials being held in China than ever before, clinical trial supply systems need to become increasingly sophisticated in order to cope with local regulations, importation and exportation guidelines, application of licenses, transit, packaging and labeling requirements, temperature-controlled storage and transportation and local distribution. In this quickfire Q&A we speak with Wang Tao, Head of Clinical Operations at Genzyme, about the the clinical trial supply issues faced by the pharmaceutical industry in China.
Pharma IQ: Please could you tell us a bit about your current role and responsibilities?
W Tao: I lead the clinical operations team in Genzyme China and I am responsible for the team and people development, as well as the recourse allocation and quality control for all global and local clinical trials conducted in China.
Pharma IQ: What are the current trends you are witnessing in the clinical trial landscape?
W Tao: China is becoming more and more important and is expanding very quickly in the clinical trial industry.
Pharma IQ: Indee, without any question, China has become one of the most attractive regions for global clinical trials in the past years, most international pharmaceuticals have increased their reliance on China for its rapid patient enrolments and relatively lower costs. What do you think are the opportunities and challenges for conducting clinical trials in China and Asia?
W Tao:The opportunities are rapid economic development and the big population in China. Challenges could be less experiences for site, investigator and patients in clinical trials.
Pharma IQ: How are you leveraging software technology to improve the management of clinical operations?
W Tao: Enhancing training for internal and external stakeholders and introducing more and higher standards clinical trial to China.
Pharma IQ: Are we gaining the full benefit of ‘e’ business for clinical research?
W Tao:Sure. More and more e business were introduced into clinical trial like EDC, IVRS, central testing, Etmf, eDocumentation, etc.
Pharma IQ: What would be your top 3 tips for effective clinical operations?
1, people/talent development and retention
2, professional outsourcing
3, effective matrix
Pharma IQ: I understand you are going to speaking at the the 3rd annual Clinical Trial Supply China event. What are you most looking forward to about the event?
W Tao: Aligning the relative regulations with government and agency and finding the best way to cooperate between sponsor and CRO.
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