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2015 ; 3
(2
): 85-88
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Roles of contract research organizations in translational medicine
#MMPMID30035044
Shih MS
J Orthop Translat
2015[Apr]; 3
(2
): 85-88
PMID30035044
show ga
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 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.
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