Why use EDC if eSource has the endpoint data? In the CRIO article, Automate the protocol with eSource, we described how CRIO eSource automates the protocol, building compliance at the point of capture. CRIO is often asked if we can send the data to the EDC. The answer is yes, if the EDC system’s API...
Hiding in plain sight – CRIO eSource is the biggest opportunity for sponsors. While the clinical research industry has automated many processes, there is one area that is still mostly paper-bound. This is the source of one of the greatest inefficiencies in research today. Automating this one process could drive 20% cost savings in a...
The new FDA guidance to enhance diversity in clinical research subjects has brought ethnic and racial diversity to the center stage for sponsors. In this document, the FDA encourages sponsors to develop a Race and Ethnic Diversity Plan to incorporate into each protocol. More specifically, the FDA suggests that to achieve these diversity targets, sponsors...
Enrollment is critical to a trial, and site performance is a major – if not the most important – driver of that. We’ve always known that our full stack system enables sites to increase efficiency and enhance data quality, but do sites who use CRIO actually enroll more? We now have data to prove that...
CRIO’s integrated eSource-EDC model revolutionizes both the data entry process at the site level and the monitoring process from the CRO perspective. According to a third party survey of CRAs who have used CRIO, CRAs agreed by a margin of 23:1 that this new model would increase overall trial efficiency, improve data quality, and enhance...
Overview This past April, the FDA released updated guidance to sponsors and pharmaceutical companies on increasing racial and ethnic diversity in clinical trials to propel more inclusive research. Racial and ethnic minorities have historically been underrepresented in research,1 even within diseases where they make up the majority of those affected. The FDA also advises sponsors...
Over 13,000 protocols have gone through the CRIO system, and in the vast majority of them, CRAs have used CRIO to monitor source. We’ve always heard from our sites that their CRAs love the system, but now we have proof. According to a third party survey of CRAs who have used CRIO, by a healthy...
Entry of pharmacy chains into clinical research CVS Health CVS Health was the first of the major pharmacy chains to publicly enter the clinical research space when they launched CVS Health Clinical Trial Services in May 2021. They launched this new business arm initially to facilitate clinical trials for COVID-19 vaccines and treatments. While the...
Networks are brick and mortar businesses by definition, but their differentiation lies in their ability to incorporate and optimize technology in every step of the workflow. No single technology vendor will be able to service the full gamut of needs. Instead, leadership teams should select and configure optimal solutions for different stages of the value...
There are plenty of instances where institutional capital goes into a sector, only to fizzle out. Why are we confident that the site network trend is real, and not hype? We’ve identified 4 main levers of revenue and profit growth for network consolidation. In order, from the “quick hit” to the heaviest lift: Business Development...
Valuation of site for purchase by site networks As site networks compete with each other to purchase clinical research sites, certain valuation standards have emerged. For sites that achieve a scale threshold, an exit is possible at a multiple of the site’s EBITDA. EBITDA stands for earnings before taxes, interest, depreciation and amortization, and it’s...
The daunting task of COVID-19 trials The onset of the COVID-19 pandemic posed a new challenge for sponsors. They needed to execute clinical trials at a rate that has never been accomplished before. To succeed, they needed sites that could conduct the trials at unprecedented speed. These are sites with short start-up times, existing large...