Pharmaceutical / Clinical Translation
As clinical research organizations (CROs) conduct multi-geography clinical trials and pharmaceutical companies compete to seize new markets, clinical translation is more and more becoming a critical step of the process, whether to bring new drugs to market or to seize new global market shares once a drug has been approved. According to the FDA, over the past 15 years, the share of clinical studies conducted in the US has declined from a high of 80% to 24% currently. Meanwhile, however, approved drugs for which data was derived from foreign clinical trials rose from 50% in 1998-1999 to 75% today. At the same time, new emerging markets such as China or India have opened up to drug companies who compete to capture their enormous potential. Logically, pharmaceutical companies are aware of the importance of timeliness and accuracy during the translation of clinical trial documents (informed consents, case report forms, protocols) or after a drug has been approved (instructions for use, labeling and packaging, marketing collaterals).
Since 1996, Excel Translations has provided expert medical translation and clinical translation services to drug and clinical research companies such as Glaxo SmithKline, Millipore, ICON and Avigen amongst others. Our expertise helps companies like these comply with the regulations set forth by drug regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), Japan's Ministry of Health, Labor and Welfare (MHLW), and China's State Food and Drug Administration.