Global clinical trials and language barriers

By Leo Galperin posted 08-09-2010 11:28 AM

  

Dear Colleagues,

International outsourcing of clinical trials to all parts of the globe is no longer a new phenomenon in the biopharmaceutical industry. Among emerging Asian markets, South Korea is quickly becoming a dominant outsourcing location for clinical trials. This is mostly due to a quickly evolving regulatory environment, streamlined regulatory approval, reduced costs, and more successful patient recruitment relative to many developed Western countries.

 

We have recently published an article entitled "Korea Path" (pp 30-36) which discusses the country's current clinical research environment, including the challenges that must be addressed by foreign companies.

What are the translation requirements? How do cultural differences affect medical practices? What is the current regulatory approval process?


As a language service provider for over fifteen years, we are well aware of the importance of native language communication, especially in the translation of clinical trial documents. Our life science experts have translation experience in over one hundred languages, including Korean, and other dominant Asian languages.

Since we are continually learning about the industry, I am interested in hearing your opinion about this topic and about cultural and linguistic issues as they apply to companies interested in outsourcing.

Best wishes,

Leo Galperin

1 comment
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Comments

08-15-2010 11:37 AM

Leo,
Outsourcing is a reality. Successful pharma companies and CRO's need a world wide presence in order to succeed in today's market place. In my opinion, this model works best when a company has an actual physical presense in the developing countries involved in the research. Local / Regional Leads, based in the country, understand the regulatory requirements for their region. These leads are also aware of the different language requirements in the region and are able to provide a realistic list of the translations needs. Global team meetings (via teleconference, web-ex with some held face-to-face) keep the entire team in the loop. The "lessons learned" from venturing into emerging markets will help pave the way for a smoother process the next time. In order to be successful, we have to embrace the cultural difference and respect what the emerging countries have to offer the global research community.
“Languages are the pedigree of nations” - Samuel Johnson