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 Gene Therapy studies in Australia. All necessary license and notification applications require review from an IBC before successful applications can be submitted to the OGTR.
ABOUT THE IBC
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 Gene Therapies) through internal processes for obtaining and holding licenses from the OGTR on behalf of clients. CNS can act as the sponsor for the DIR licence 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 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 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