Roles of contract research organizations in translational medicine.

Transitional medicine/science is shifting the medical research paradigm from compound-based to evidence-based drug/device discovery. It is increasing interdisciplinary collaborations, enhancing usage of advanced technologies, and facilitating therapeutics reaching patients faster. The fundamental theme of evidence-based discovery is to apply what is revealed in preclinical experimentation and to bring the resulting safety and efficacy to clinics. In the medical fields, a contract research organization (CRO) works like a hired agent who has corresponding knowledge and experience to conduct and complete tasks for a sponsor. The relationship is business, and the contract is for deliverables. The increasingly high volume of sponsored outsourcing work has made this for-profit business boom in the past decade. Location boundaries are being blurred under globalization in the sciences and cross-border regulatory reviews. Getting from bench to bedside is a winding road with many obstacles and high hurdles. Efficient teamwork becomes essential to materialize ideas and bring them to the market. The professionals within team communities include drug/device makers and CROs. It has become increasingly obvious that CROs play pivotal roles in the chain of discovery/design, developing product to market through