Our Services

Regulatory Submission / Sponsorship

Trident's staff has over 20 years experience in dealing with regulatory and ethical approvals of clinical trials in Australia. We are familiar with the workings and regulations of the Australian regulatory agency, the Therapeutic Goods Agency (TGA).

There are two schemes under which clinical trials involving therapeutic goods may be conducted, the Clinical Trial Exemption (CTX) Scheme which is an approval process, or the Clinical Trial Notification (CTN) Scheme, which is a notification process.

We are able to advise on the most appropriate regulatory pathway to expedite the start up of your clinical trial in Australia.

All CTN and CTX trials must have an Australian sponsor. The sponsor is that person, body, organisation or institution which takes overall responsibility for the conduct of the trial and signs either the CTN form or the CTX form.

The sponsor usually initiates, organises and supports a clinical study and carries the medico-legal responsibility associated with the conduct of the trial.

As Trident is a registered enterprise with the Therapeutic Goods Administration (TGA),we are able to act as the Australian sponsor for customers who do not have a legal entity within Australia. Similarly, we have extensive experience in the SCOTT process in New Zealand and the approvals process in India.

All of our project managers can provide guidance on labelling requirements, import permits and local indemnification and insurance issues for each region.