[This post is the first in a three-part series about the transformations that are occurring throughout the clinical research industry and Clinipace Worldwide’s effort to bring more efficiency and transparency to the process.]

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.

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 mis-communication. With the traditional Contract Research Organization (CRO) 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 public-private 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.” –    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.

A new paradigm shift (Clinical Research 3.0) is now transforming outsourced clinical research and is giving rise to a new kind of contract research organization. The new paradigm is characterized by the Digital Clinical Research Organization (dCRO) which is enabled by widespread adoption of technology and constitutes no less than a change in the philosophy underpinning clinical research.

More on the dCRO in our next post!

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