CRIO is and continues to be the eSource market leader for clinical research sites. Today, for many common therapeutic areas, CRIO sites represent anywhere from 10 to 60% of U.S. sites participating in the study.
On average, 1 in 4 U.S. sites engaged in chronic condition trials are CRIO clients
Based on a review of 50 recent studies, 28% of the U.S. sites, on average, are current CRIO clients. This analysis is based on manual review of the individual sites listed for the studies on clinicaltrials.gov. These recent studies represent phases 2 and 3, average over 80 U.S. sites total, and represent 10 different pharmaceutical companies.
By therapeutic area, CRIO has the highest representation on vaccine studies, averaging nearly 50% on high-enrolling vaccine indications such as COVID-19 or the seasonal flu. This is consistent with a trend CRIO identified over two years ago, when we calculated that on the pivotal Pfizer and Moderna COV-19 studies (the ones submitted to FDA for approval of the vaccines), then-current CRIO clients represented roughly 30% of the U.S. sites.
Other highly represented therapeutic areas include metabolic dysfunction-associated steatohepatitis (MASH) (averaging roughly 45%) and obesity or Type 2 diabetes (averaging roughly 30%).
CRIO’s high penetration reflects our wide adoption by larger site networks, who represent an increasingly significant portion of the sites selected on trials. (CRIO has written extensively on this trend, most notably this 2023 analysis.)
Central eSource allows sponsors to extend this adoption
Many times, when CRIO site penetration is lower, we notice that a significant number of the U.S. sites are not necessarily large academic centers or hospitals, but small, community-based physician practices.
While these sites can thrive through their access to targeted populations and their long-standing relationships with sponsors, many are simply too small, from both a budget and a resource perspective, to make a wholesale change in processes to operationalize their own eSource system.
For this reason, CRIO’s Central eSource is a perfect opportunity to expand adoption of CRIO. Higher CRIO adoption among sites directly benefits sponsors through accelerated site start-up times, improved data quality due to real-time validation, and enhanced protocol compliance. This streamlined process leads to more efficient trials, reduced monitoring costs, and ultimately, faster time to database lock and regulatory submission.
Many of the smaller independent sites are not even aware that eSource is an option, or, if they are, they simply haven’t had the manpower required to vet, train up on, and implement a largescale system like eSource. But when the sponsor offers the system, along with a centrally pre-designed template and training and support from CRIO, many jump on the chance.
In a recent global phase 3 study CRIO was able to achieve 70% voluntary site adoption overall. Many of the new-to-CRIO sites represent smaller independent sites being introduced to eSource for the first time. Preliminary feedback has been highly positive – higher, in fact, than the feedback from CRIO’s own client sites! (We speculate this is because CRIO client sites are already used to working with CRIO so the novelty factor is lower.)
“CRIO is very user friendly, especially compared to other eSource platforms I’ve worked with. I hope this is the future of research.” – new-to-CRIO site
“CRIO’s Site Enablement team is on top of communication, leading educational sessions, and assisting at every step of the way.” – new-to-CRIO site
Ex-US, eSource is growing, and sponsors can accelerate adoption
In recent years, markets outside of the US have been the fastest growing for CRIO – with strong adoption in Canada, the United Kingdom, Australia, Germany, Poland and Brazil. Many of these markets are where the U.S. was 4 or 5 years ago; it’s not uncommon for CRIO site penetration to hit 20% in these markets.
That said, there are still many markets where eSource adoption has been limited. To address this, CRIO is internationalizing its software to fully support Spanish, Portuguese, German, French and Polish versions. CRIO has also developed an API that allows sponsors to extract a completed study build (i.e., in English) and then ingest the translated builds (e.g., in Spanish or German); this facilitates rapid creation of translated templates for publication to global sites.
It’s with these smaller markets where eSource awareness is low that sponsors can achieve significant gains from promoting Central eSource. Many sites in low-awareness markets are reluctant to adopt new technologies over concerns about sponsor acceptance, so when they see sponsors promoting eSource adoption, they will be much more likely to participate.