For more than 25 years, Novotech has delivered over 700 early-phase studies across Australia and New Zealand, establishing a strong regional footprint and reputation for operational excellence. As the leading CRO in the region, Novotech is the partner of choice for international biotech companies seeking trusted expertise, regulatory insight, and dependable early-phase execution.

Our early Phase services include:

  • Full study project management – regional and international
  • Protocol development & Investigator Brochure (IB) writing
  • Site identification and selection (including phase 1 units for healthy volunteer studies)
  • Study implementation including ethics and regulatory coordination
  • eCRF design and implementation
  • Full data management
  • Biostatistics (including PK/PD analysis and modelling)
  • Site management/monitoring
  • Third party Pathology/Bioanalytical laboratory analysis & reporting
  • Australian & New Zealand local sponsorship
  • Serious Adverse Event (SAE) reporting and Local Medical Monitoring (LMM)
  • Clinical Study Report (CSR) writing

Expedited product development using Australia and New Zealand

The regulatory environment in Australia and New Zealand offers a significant strategic opportunity for international biotech companies who can take advantage of a uniquely fast and pragmatic regulatory pathway for early phase clinical trials. Uniquely, through its Novotech Drug Development Consulting team, Novotech is able to provide gap analysis and critical assessment of client’s pre-/non-clinical data to ensure our client’s package is ready and suitable for submission.

The simplicity and efficiency of the Australian and New Zealand Regulatory and Ethics (IRB) processes often means our clients can defer regulatory submissions in other regions by initiating their clinical programs in Australia and/or New Zealand and commencing subject treatment within a single review cycle of 6-8 weeks from submission.

The outcome for our clients include:

  • Defer costly IND/CTA submissions when capital is precious - if you’re ready to submit an IND/CTA then you are likely ready to commence trials in Australia or New Zealand
  • Obtain POC/FIH data earlier in your development timeline
  • Achieve earlier ‘next round’ funding supported by POC/FIH data
  • Submit more complete/meaningful IND/CTA applications
  • Make a faster go/no-go decisions