Coastal Pediatric Research outlined what they wanted an eRegulatory system to provide, which included 21 CFR Part 11 compliance, a user-friendly interface, regulatory binder structure flexibility, the elimination of duplicate work, the ability to streamline signatures, and an integration with their clinical trial management system (CTMS). After seeing a demo, Coastal Pediatric Research was confident the RealTime-Complion eRegulatory solution would meet all their requirements.

Dr. Jeff Kingsley is CEO of IACT Health, a 14-site research network based in Columbus, Georgia. IACT Health is also a founding partner in hyperCORE International, a “super network” of clinical research organizations with over 90 investigative sites worldwide. Recently, Dr. Kingsley received a call from a Contract Research Organization (CRO) based in Southeast Asia. The CRO was managing an Atopic Dermatitis clinical trial in which patient-recruitment by the sites originally selected to complete the study had stagnated while still 30 patients short of the required number of subjects.

NHC needed a new eRegulatory system to streamline processes and reduce administrative burdens, and wanted a hassle-free transition for their site-based clinical research teams.

A highly respected and top-performing site organization was challenged by the inability to accurately measure turnaround times without cumbersome spreadsheets. This was additionally complex given its 14 locations and 54 investigative sites, spread across the mid-Atlantic region of the U.S.