George Clinical Awarded Taiwanese Drug License

SYDNEY, May 15, 2019 /PRNewswire/ -- George Clinical, a global scientifically-backed clinical research organization (CRO), has significantly expanded its capabilities in Taiwan having been granted a license to import drugs into the country for clinical trials on behalf of sponsors. The development will be particularly helpful for small to mid-sized clinical trial clients who do not have an entity in Taiwan by simplifying and accelerating their path to an operational drug study.

CROs without such a license must rely on large individual pharmaceutical companies to import the drugs on their behalf which leaves small to mid-sized clients with no simple ability to manage drug trials in Taiwan. The granting of the licence positions George Clinical as a one-stop-shop, highly competitive provider for sponsors looking to add Taiwan into their trial countries. To manage an investigational medicinal product (IMP) in a clinical trial, the research organizer must hold a wholesale drug license. George Clinical now offers these key services including drug importation for both renewals and amendments, IMP stock management, re-labelling, return and destruction.

"Like other clinical research organizations without a drug licence in Taiwan, previously we could only provide project and site management to our clients without the critical support for drug management," said Evon Hui, Head of Business Operation, East Asia. "We were lucky to be able to rely on a few large pharmaceutical firms' local affiliate's drug licence to import drugs in previous trials. With our own drug licence, however, we have great flexibility to serve mid-size biotech firms who do not have a local entity in Taiwan."

Small to mid-size biotech clients benefit greatly from a CRO who can provide a one-stop service for drug studies, including the components of IP management. George Clinical can now extend services for clinical trial application related activities including new applications, amendments, closure and inspection after clinical study report (CSR) submission as well as IMP management on behalf of the sponsor.

"With the top prevalent diseases in Taiwan including cancer, heart disease, pneumonia, cerebrovascular disease and diabetes, we hope to help bring meaningful drug research results to our clients in all of these areas over time in turn generating increasingly effective health care," said Hui.   

About George Clinical
George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With 20 years of experience and more than 300 staff that cover 38 geographical locations throughout the USA, Asia-Pacific region and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.  

SOURCE George Clinical

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