Local Legal Entity
In Australia and New Zealand, the sponsor of a clinical study must be a local legal entity registered with local regulators. CNS acts in this role for the majority of
overseas clients and therefore assumes local sponsor responsibilities and liabilities as summarised below. All such costs are typically eligible for the Australian R&D tax incentive claims.
CNS will act as required under regulatory authority rules (Therapeutic Goods Administration (TGA) in Australia and MedSafe in New Zealand) and will be responsible for the following:
Review of product labelling to ensure local compliance of all inner and outer product packaging
Complete/sign necessary regulatory submission documents
Complete/sign and maintain study indemnification
Report any Serious Adverse events that are determined to be unexpected or related to the Investigational Product (or comparators), termed SUSARs, to the local regulatory authority.
CNS can also source study insurance however the client must maintain suitable study insurance compliant with country requirements
In Australia, the protocol will be submitted for regulatory acknowledgement only via the Australian Clinical Trial Notification (CTN) scheme. Under this scheme regulatory review is undertaken by the HREC and not the TGA. Upon approval of the protocol by a HREC, Institution (Governance) and the Investigator, a CTN form is submitted to the TGA online by the Australian Sponsor (CNS) along with a per site payment. The TGA provide acknowledgment only (not review) within ten (10) calendar days. Should the TGA or HREC deem that this study may not be conducted via the CTN scheme, a full Clinical Trial Exemption (CTX) submission would be required to the TGA.
In New Zealand, CNS will prepare a submission document (electronic format) and submit to the New Zealand Ministry of Health's (Medsafe) Standing Committee On Therapeutic Trials (SCOTT). The submission to approval timeline currently averages at ~14 days. A SCOTT approval is required for non-registered drug formulations, but not for medical devices, nor new indications of NZ registered formulations. SCOTT applications cost NZ$6,525 (around AUD$6,500) with no charge for Ethics Committee applications.
CNS SOPs will be used in the conduct of all activities performed by CNS unless otherwise requested and following training of applicable CNS staff on client SOPs.
CNS can also register the study on a Clinical Trial Register in accordance with local regulations on behalf of the client unless otherwise directed.
Through our offices in the USA and UK, CNS also acts as local legal entity for non-clinical trial activities.
To find out more, contact us