The Novotech group has 25 years of experience completing hundreds of early phase clinical trials in healthy volunteers and patients across Australia and New Zealand. Novotech is one of the most experienced local providers within the Australian and 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 if healthy volunteer study
- 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 BioDesk 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