Fast2First
Australia’s outstanding advantage for early stage clinical trials lies in the availability of a fast and pragmatic regulatory pathway. Full regulatory submissions to the FDA or EMA can be deferred until projects are advanced enough to know whether they stand a chance of success. This is the ideal regulatory framework for biotechnology and biopharmaceutical companies who need to achieve clinical proof of concept and a value-driving licensing deal with the minimum of outlay.
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Under the “Fast2First” service brand CNS provides its biotechnology and biopharmaceutical clients with the full range of Phase I and Phase II clinical trial services from protocol design all the way through to Clinical Study Report writing. Using its extensive experience in the local research environment realises the Fast2First advantage through is close associations with the network of Phase 1 units, Clinics and Hospitals across Australia and New Zealand.
CNS’s Fast2First services include the following:
- Overall Project Management
- Site Management and Monitoring
- Trial Master File/Regulatory Binder Maintenance
- CRF Design and Data Management including EDC Solutions
- Data Safety Monitoring Board/Committee Co-ordination
- SAE Collation and Reporting including Local Medical Monitoring
- Biostatistical Analysis including PK/PD Parameter Analysis
- Clinical Study Report Writing
- Study/Site Audits
- In Country Sponsorship/Local Legal Entity
- ISO 17025 and GLP Accredited LC/MS/MS Bioanalytical Laboratory Services for PK/PD Assay Development/Client Tech Transfer/Existing Validated Assays.
Fast2First is a brand developed by the TriAlliance strategic alliance of CNS alongside CPR Pharma Services (CPR) headquartered in Adelaide, Australia, and Beltas, headquartered in Auckland, New Zealand. Further details on the combined offering of Fast2First by TriAlliance can be found on the following website: http://fast2first.com/