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Solid as a ROC: Strengthening your research operations core

Sarah M. Couture (sarah.couture@ankura.com) is Managing Director and Brian D. Annulis (brian.annulis@ankura.com) is Senior Managing Director at Ankura Consulting Group in Chicago.

Since the inception of ClinicalTrials.gov, “a database of privately and publicly funded clinical studies conducted around the world,” in 2000,[1] the volume of registered clinical trials in the United States has skyrocketed. As of August 9, 2020, there were 115,883 active clinical trials in the United States.[2] Commensurate with the growth in registered clinical trials, there has been increased oversight and regulatory focus on clinical trials, including Common Rule updates,[3] billing compliance enforcement, scientific misconduct investigations, conflict of interest inquiries, and kickbacks and related enforcement actions, to name a few. As institutions pursue clinical research opportunities, whether industry sponsored or investigator initiated, it has never been more important for institutions to have solid administrative and operations processes to support their clinical research billing—what the authors of this article call research operations core (ROC) workstreams. Well-grounded processes not only help mitigate billing compliance risks, but also support efficient clinical research and contribute to the overall research strategy and financial success of the institution.

Our country is replete with world-class clinical research programs and brilliant scientists pursuing novel clinical discoveries and innovative treatments such as new drugs and medical devices. Behind the names and even potential fame and glory of these clinical research programs and investigators are the necessary administrative functions and staff that support them. While these ROC workstreams and staff may be far less flashy or recognized than the science or the scientists, they are the essential backbone of successful clinical research programs.

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