Author Archives: Agilex Biolabs

The reality is, Australia has fantastic key opinion leaders, some great principal investigators that have been running clinical trials for decades. The CROs, RFA with FDA and EMA requirements. And in fact, our whole Australian service provision industry sets itself to that standard because ultimately that is the client base that Australia is servicing. Most CROs in Australia and service providers will be able to talk about situations where their data has been presented to the FDA or EMA with success.
One of the most important drug development start-up decisions is finding a centrally located bioanalytical laboratory that can support clinical research across all the study locations, and through pre-clinical then potentially for all Phases.

Quality control and consistency of sample management and analysis from early Phase onwards can make a real difference to quality of data and final outcomes.