CNS initiated the first national, privately owned, commercial IBC in Australia, successfully accredited by the Australian Office of the Gene Technology Regulatory (OGTR).

Having access to an Institutional Biosafety Committee (IBC) is a prerequisite for an organisation to obtain and maintain accreditation for the conduct of studies using investigational products that are genetically modified organisms (GMOs) in Australia. All necessary license and notification applications require review from an IBC before successful applications can be submitted to the Office of the Gene Technology Regulator (OGTR).  


Mark Reid BioDesk IBC GIF
Mark Reid

Simone Flight
Dr Simone Flight

Layne Wright CNS IBC
Dr Layne Wright

Barbara Kienast CNS IBC
Barbara Kienast 

Paul Griffin IBC
Dr Paul Griffin

Kim Lowry CNS IBC
Dr Kim Lowry

As an accredited organisation with the OGTR, CNS' IBC not only supports the reviewing and submission of license and notification applications but is also able to streamline Australian sponsorship for clinical trials (using GMOs) through internal processes for obtaining and holding licenses from the OGTR on behalf of clients. CNS can act as the sponsor for the Dealings Not Involving Intentional Release (DNIR) or Dealings Involving Intentional Release (DIR) licence and Notifiable Low Risk Dealings (NRLDs) covering the client, distributors, laboratories and sites. This will necessitate annual auditing of selected sites covered by the single licence to ensure licence conditions are met. A report will be prepared for client review for each site and will form part of the annual OGTR report. In this way, we can seamlessly offer full clinical trial services without disrupting the program timelines.

If a company has a legal Australian entity, they can choose to be the applicant and hold the DNIR or DIR license however, it is the responsibility of the license holder to ensure the conditions of the license are upheld. There are advantages for CNS taking this responsibility instead as CNS can also be responsible for monitoring the study.

CNS will provide ongoing support throughout the evaluation phase of the DNIR or DIR with the OGTR and will respond to questions raised by the OGTR in writing following consultation with our client.


To find out how CNS’ fully accredited IBC can assist you or to request our team bios, contact us