Fast2First – through the pragmatic ethics and regulatory process

Fast2First offers a network of Phase 1 units, Clinics and Hospitals across Australia and New Zealand and a suite of services unmatched in the region. The combination of Clinical and Data management services coupled with a GLP bio-analytical laboratory means the FAST2FIRST service can deliver on a suite of services that can seamlessly take a company through initial FIH trials through to Phase 3 with a single point of contact and one master service agreement. This kind of relationship efficiency and decreased administrative burden is increasingly demanded by companies who to date have had to look to larger, global CROs to achieve this.

Our outstanding advantage as described in the illustration below is the availability to a fast and pragmatic regulatory pathway for phase 1-2 studies. The availability of the Clinical Trials Notification (CTN) Scheme means that our clients can put the need to submit full regulatory submissions to the FDA, EMA, etc to one side and submit directly to Australian Ethics Committees (IRBs) who under the CTN scheme assume the typical regulatory review responsibility. This review is done within a usual review cycle of 4-8 weeks based upon a protocol Investigator Brochure and perhaps an independent toxicology report. The result is that a much faster timeline into the clinic, avoiding lengthy Regulatory Authority reviews and costly submission dossiers meaning better utilization of limited funding available to many small biotechnology/bioPharm companies.

The second advantage that our clients enjoy is that they get access to first in human/patient data much earlier in the development timeline allowing our clients to achieve better later funding success as they have real clinical data available and as all data from Australasia is readily acceptable by the FDA, EMA and other regulators, IND and CTA submission can now be made with more confidence and likely success. The Fast2First strategy is one used by many of our clients to great success, many of whom continue to return to us to continue their products development through phase 2-3 but also to repeat the process with their rest of their pipelines.

Australasian Early Phase Advantage

When coupled with the fundamental regulatory advantages in the region Fast2First as managed by TriAlliance presents a refreshing refocus on the needs of biotech and Pharma as the markets recovers from the investment crunch of the last few years.

• No IND/CTA required
• No Reg for Devices in NZ
• 10-14 days Regulatory Approval period in Aus & NZ
• Single NZ IEC & mutual recognition across many Aus ethics
• Reliable Recruitment from a mature and motivated clinician base
• Extensive network of phase 1-3 clinicians and units to suit your needs
• Counter-seasonality for flu, allergy