Roles of contract research organizations in translational medicine

Abstract

SummaryTransitional 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 in vitro, in vivo, and ex vivo testing during preclinical experimentations and clinical trials. Project management teams are responsible for nurturing the materialization in a collaborative manner and enhancing the productivity of the pipelines. CROs have many functional aspects and specialties, and no one organization is fully capable of serving, i.e., integrated services, with expertise in each step of the chain to the needs of a variety of sponsors. Instead of competition among the CROs themselves, the continuously expanding market demands can be shared by Expertise-Based Integrated Services among allied CROs, in contrast to the few large CROs. Empirically, the data generated from the chosen CROs should meet the regulatory requirements for approval. A quality assurance unit from the sponsor should be vigilant in performing audits and inspections of the candidate CROs prior to contracting. Subsequently, close monitoring and well-organized project management guard the path to the successful filing of the applications. A strategic alliance of translational medicine with CROs ensures proven therapeutics for disease treatment and prevention to be connected with patient populations in a timely and cost-effective manner. The unbiased data generated through CROs' services can be used for a patient-driven approach in drug discovery and device control design. Thereafter, findings from the merged efforts can promote and complete the feedback loop for refining existing medicines and exploring new medicines. A matchmaking business may emerge and evolve from the procurement department of the inventor in translational medicine and the business development sector of the CROs to generate a new landscape in translational medicine.