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...
Recruitment & Diversity
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...
Running a Site
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...
Running a Site
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...
Running a Study
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...
CRIO Company News
BOSTON, MA – August 9, 2022 – CRIO, a Boston-based healthcare technology company streamlining clinical trials for sponsors, sites and patients, announced that it has reached another milestone, exceeding 2,000 clinical research sites standardizing on CRIO’s eSource platform. CRIO supports a variety of clinical trial data. To date, over 800 life science sponsors have data...
Should we be learning how to cope with the complexity of remote/virtual monitoring, or is it more important that we learn to cope with change itself? How can industry stakeholders encourage and drive transformational change, while being mindful of the common thread that regulatory compliance must play in the framework? In Part 4 – QA/QC...
Running a Site
Patient recruitment has long been a primary challenge within clinical trials. Looking to give your site an edge in 2021? In Part 2 of our dynamic 7-part webinar series, How Research Sites Can Win with De-centralized Trials, our panel of industry experts dives into patient recruitment. Topics covered over the course of 7 sessions include:...
Running a Study
How did you get into clinical research? During medical school, I completed several research externships and became very interested in research, but did not think of it as a career. After graduating and moving to Florida for residency, I met a local physician who was a principal investigator and owned a clinical research site. We...
Running a Site
Achieving representative enrollment – meaning diversity in race, age, gender and socioeconomic status – in clinical trials is essential to the development of cutting-edge therapies for the general population. Despite being recognized as a need within the industry, it has proven to be a longstanding challenge. According to the 2019 ‘Drugs Trials Snapshots’ report released...
Running a Site
COVID-19 trials have quickly become the top trafficked listings. According to WCG Insights, COVID trial listings represent 15.1% of total visits in the last 6 months and has led to a decrease in interest in trials for other conditions. Given the fluid nature of the pandemic and the increasing need for COVID treatments and vaccines,...
Running a Site
Dr. James Clark of Charlottesville Medical Research recently had an FDA inspection of his site as it is a high enroller. He did not receive a FDA Form 483, and he was using the CRIO electronic source system on the study. Learn about his experience in this Q&A session. CRIO: What’s your background? Dr. Clark:...
