Clinical Trials Support

 Australia’s robust and efficient regulatory system makes it a popular destination to undertake early phase clinical trials, in particular FIH trials, and to include the study results in IND and marketing applications as well in communication with VCs.

Sample Analysis
TetraQ provides non-routine and routine analysis of samples collected in clinical trials. These bio-analytical services can include pharmacokinetic studies involving WinNonLin (validated).The accuracy and precision of these studies are designed to suit the stage of development and include common PK parameters (e.g., Cmax,Tmax, t1/2, AUC, Cl, Vd, F):

• Dosing via intravenous, oral, subcutaneous, intraperitoneal or intramuscular routes
• Assessment of Bioavailability

Speed
TetraQ does not undertake clinical trials but has access to a network of early phase clinical research units in Australia and S-E Asia, as well as regulatory advisors, in order to transition investigational compounds smoothly from preclinical to clinical trials. Speed is the key word.

TetraQ regularly conducts ADME-bioanalysis studies in cooperation with the following phase I/II CROs:

• Q-Pharm Pty Ltd
• Nucleus Network Pty Ltd
• Info Kinetics Sdn Bhd

TetraQ collaborates with the following regulatory consultants:

• Ground Zero Pharmaceuticals, Inc. (GZP)
• ERA Consulting