Regulatory & ethics (IRB) applications for clinical studies

BELTAS arranges and assists with regulatory applications in New Zealand, Australia and in Europe.

New Zealand's regulatory authority is Medsafe (www.medsafe.govt.nz"). Australia is governed by the Therapeutic Goods Agency (TGA - www.tga.gov.au).

European authorities are governed by the implementation in legislation of the 2001 EU Directive and subsequent amendments.

BELTAS has a comprehensive understanding of local regulatory application requirements for clinical studies. Applications are made in parallel with Ethics Committee submissions, and trials are carried out to national guidelines laid out by the International Conference on Harmonisation Good Clinical Practice (ICH-GCP).

We collect, maintain and distribute essential documents to both the sponsor and the regulatory authority, as required by trial protocols.

BELTAS assumes local sponsorship in New Zealand and Australia if required. In Europe, sponsors are required by the EU Directive to have a registered office.

For country-specific details please refer to our FAQs

BELTAS arranges and assists with ethics applications. Ethics committees don’t charge a fee in New Zealand and one application covers all sites. Australian ethics applications are usually per site and a fee is payable. There is also a private ethics committee available for some studies - usually those conducted through private clinics.

European ethics committees are governed by the implementation in legislation of the 2001 EU Directive and subsequent amendments.

For country-specific details please refer to our FAQs

"Patient recruitment consumes more time than any other clinical trial activity, with thirty per cent of clinical trial time spent finding and enrolling study subjects"

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