Conducting Innovative Early Phase Research
The seemingly ever-increasing cost of drug development continues to force sponsor companies to try and find innovative ways to conduct their clinical studies. This is especially true for early phase studies where a creative study design could aim to achieve several objectives which may include pharmacokinetic sampling, thorough QT/QTc, single- or multiple-ascending doses, food effect, etc.
Our early phase teams provide innovations in translational medicine techniques – bench to bedside strategies – supporting success early on. Azelix offers comprehensive services for the outset, incorporating comprehensive services to ensure success.
Termed Translational or “bench to bedside” medicine, the concept forms the initial basis for evidence-based practice and clinical guidelines. In the case of drug discovery and development, translational research typically refers to the translation of non-human research finding, from the laboratory and from animal studies, into therapies for patients. Azelix Early Phase uses many facets of translational medicine to facilitate the interaction between basic research and clinical medicine to design and conduct clinical trials including use of biomarker endpoints, bioanalytical methods, adaptive trial design and collaborative scientific teams over multiple disciplines.
This thoughtful design of studies in the Early Phase translates to efficiencies through-out late phase studies, affecting success rates of bringing promising compounds to a successful approval status.