Our clinical team have almost 20 years’ experience working on 500+ early phase studies, making us an exceptionally experienced local provider within the Australian & New Zealand market and a partner of choice for many international biotech companies.
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 entity & 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
- Phase 1 studies – ‘GMP-like’ is acceptable