Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.

The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.

Avance Clinical CEO Yvonne Lungershausen said OGTR accreditation is important for our international clients. "Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector," she said.

Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.

Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.

Other benefits include:

1. The Government R&D grant means up to 43.5% rebate on clinical trial spend

2. Telehealth pivot during COVID-19 pandemic - speed and continuity

3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks

4. No IND required for clinical trials

5. Full GMP material is not mandated for Phase I clinical trials

6. Established clinical trial environment with world-class Investigators and sites

7. Established healthy subject databases and specialized patient populations

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