Core Clinical Trial Services

We understand that the small-medium international biotech/biopharm industry business model requires a leaner, more result-driven paradigm for implementation, management and reporting of early phase clinical trials. In keeping with our philosophy of not being limited by traditional CRO templates, the TriAlliance PM will lead an experienced clinical team that meets industry expectation by delivering a focussed and pragmatic suite of services.

To this end, we offer the following core clinical services either as stand alone components or as a full integrated solution;

• 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

Non-Core Clinical Trial Services

The objectives of every clinical trial are different. In its capacity as a full service provider under one contract, TriAlliance are able to source non-core services locally thus avoiding unnecessary multi-country, multi-contract solutions. The following is a non-exhaustive list of some of the trial specific services we regularly provide from within Australia & New Zealand;

• Secondary packaging/labelling, storage, importation & distribution of test products
• Australian regulatory consultancy and TGA liaison for small molecules, biologicals and devices
• Central Reading services eg Imaging, Cardiology, Psychometric
• Scintigraphy/Radiographic Labelling studies
• Some GMP Manufacturing/Destruction