SYDNEY, February 2, 2022 – George Clinical announces that the organization has been accredited by the Australian Office of the Gene Technology Regulator (OGTR) which allows it to be a licence holder for studies involving the use of genetically modified organisms (GMOs).
The addition of this capability means that George Clinical can now, under the Gene Technology Act 2000 and Gene Technology Regulations 2001, undertake DIR (dealings involving intentional release) and DNIR (dealings not involving intentional release) licensing and execute studies inclusive of the required writing of DIR and DNIR applications as well as IBC (Institutional Biosafety Committee) review. Being OGTR accredited enables George Clinical to hold a license in the name of a sponsoring company.
“With the significant number of innovations advancing drug development that involve GMO inputs and recognising the importance of ongoing advancement in this domain, George Clinical is well positioned to further extend our offerings to fully executing clinical GMO studies in Australia during all phases of development,” said Chief Business Officer, Sean Hart.
The Australian Office of the Gene Technology Regulator requires organizations undertaking work with GMOs to be accredited and strongly encourages these organizations to obtain accreditation as part of the risk management process for such studies. This accreditation enables the OGTR to assess whether an organization has the appropriate governance arrangements, resources and internal processes in place to effectively oversee work with GMOs.
About George Clinical
George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With more than 20 years of experience and 400 people managing 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.
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