Creating “Frictionless” Systems within Clinical Research
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Creating “Frictionless” Systems within Clinical Research: The Rise of the
dCRO
In recent years, most clinical trial stakeholders (Sponsors and CROs) have migrated from paper-based
clinical research processes (Clinical Research 1.0) to technology-based tools such as electronic data
capture and clinical trial management layered on top of existing (and often inefficient) methods (Clinical
Research 2.0). While these technologies have improved many aspects of the research process, they have
also reinforced existing silos among clinical trial stakeholders and clinical trial processes. Therefore, the
benefits of technology have
not been fully realized.
Diagram 1: With the traditional Contract Research Organization (CRO)
The independent systems
and software make cross talk
among functions difficult and
integration among functions
expensive. The end result is
widespread duplication of
effort and frequent
miscommunication.
model, eClinical technology is an add-on that typically adds to trial
complexity and cost, as there is an increase in “friction” points.
Opportunities for efficiency
and cost savings are lost as
information is imperfectly
transferred from one
functional silo (and
technology platform) to
another, and quality of the
overall effort suffers.
In recognition of the fact that
the traditional approach to
clinical trials is unnecessarily
complicated, the US FDA in
2007 announced the
formation of the Clinical
Trials Transformation
Initiative (CTTI), a publicprivate partnership designed to modernize clinical trials.
“. . . the clinical research enterprise needs to evolve. It needs to be much more streamlined and
efficient, and at the same time it needs to be better equipped to answer the pressing questions
that confront both patients and health care professionals.”
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Janet Woodcock, MD, then Deputy Commissioner and Chief Medical Officer at the FDA
and currently Director, Center for Drug Evaluation and Research at the FDA
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