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...
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...
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...
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...
While bugs are as natural in coding as they are in nature, we don’t want them creeping into our code. At CRIO, we have established various processes and procedures to handle bugs. At the close of 2022, we hosted a Bugathon, part of our ongoing efforts to deliver best-in-class quality. The Bugathon was a two...
In a 2019 CRIO eBook, “Scaling and Innovating: The Consolidation and Reinvention of Clinical Research Sites” we explored the emerging trend of clinical research site consolidation. Our predictions were prescient. Today, the number of institutional investors in the space has increased more than 7-fold since 2015, with no sign of abating. We at CRIO predict...
The FDA routinely audits clinical research sites, and some of those sites happened to use CRIO eSource on the studies in question. With our broad reach and history as the leading site-adopted eSource solution, we have now established a database of audit results that prove what we’ve known intuitively: CRIO eSource reduces audit risks for...
ASK ME ANYTHING WITH JONATHAN ANDRUS Jonathan Andrus, President & COO at CRIO, is an active thought-leader and presenter in the life sciences industry. He serves on the board and executive committee of the Society for Clinical Data Management (SCDM) and is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative. In this...
Overview With 9 locations in Texas, California and Louisiana, Benchmark Research is the world’s leading vaccine network. Benchmark has performed over 10,000 studies on over 40,000 subjects and has received numerous awards, including being a five-time recipient of the Best Clinical Trial Site/Network award from the World Vaccine Congress. Challenge Historically, Benchmark used paper charts...
BOSTON, MA – November 3, 2022 – CRIO, the industry’s leading eSource provider, announces the appointment of Dr. Margaretta Nyilas to its Board of Directors, effective immediately. Dr. Nyilas is a biopharmaceutical executive with over twenty years of diverse global industry experience, formerly at Otsuka Pharmaceuticals, Bristol Myers Squibb and Click Therapeutics. She has a...
This document describes CRIO’s integrated eSource/EDC model, in which source data is collected electronically by the site using CRIO’s eSource system, then transmitted automatically to CRIO’s Reviewer EDC module or to legacy EDC systems, which allows sponsors to review, query, code, lock and extract the data. This model unlocks significant savings for the sponsor/CRO, mainly...
