The partnership addresses key concerns for clinical trial sponsors as they transition to virtual trials in light of the COVID-19 pandemic.
Science 37, the industry leader in decentralized clinical trials, and Advarra, a leading institutional review board (IRB), have partnered to expedite approvals on COVID-19–related virtual trials. The partnership will help companies continue clinical research during the pandemic by allowing them to make quick adjustments to protocols for existing ongoing trials, including to virtualize these trials, and have the changes expeditiously reviewed by an approved IRB.
“We have selected Advarra as our IRB partner in this critical process given their reputation for scientific rigor, quality, and speed,” said Darcy Forman, vice president of clinical trial operations at Science 37. “Science 37 has already worked with a variety of sponsors to rescue ongoing trials, and we’re confident that Advarra, which has extensive experience with COVID-19 protocols and provides priority review for these studies, can help sponsors make the necessary adjustments to ensure patient safety.”
The virtual research model has become the standard of clinical research in the current climate given the massive worldwide quarantine measures currently in effect and the need for those with COVID-19 to be isolated. Science 37’s research is powered by the industry’s first and only comprehensive platform purpose-built to support virtual or decentralized clinical trials, and the company has conducted more fully decentralized, interventional clinical trials than any other organization.
Advarra IRB reviews are delivering priority turnaround times for COVID-19 research in as little as 48 hours. The company also offers industry-leading institutional biosafety committee (IBC) reviews that are fully coordinated with IRB reviews, plus an IBC-ready model that can help sites register with the National Institutes of Health and reduce start-up time. These capabilities, when combined with the proprietary platform and virtual trial expertise of Science 37, enable agile and transparent study start-up.
“We have worked closely with sponsors and CROs throughout the COVID-19 crisis to help ease the burden on research sites and provide support to local IRBs,” said Jeff Wendel, President of Advarra. “As the industry navigates the pandemic, we will continue to find new ways to utilize our expertise and technology to advance clinical research during these challenging times. We’re thrilled to partner with Science 37 to help expedite COVID-19 trials.”
Patient recruitment and retention are being dramatically impacted by the COVID-19 pandemic, and as a result, trial sponsors are developing risk mitigation strategies to ensure that patients can safely continue to participate in research. The current health landscape has driven many companies to virtualize aspects of their research to minimize in-person interactions, employ telemedicine wherever possible, and have study medication and supplies shipped directly to patients—elements that the Science 37 virtual model already provides.
About Science 37
Science 37 is making the promise of virtual trials the new reality. By engaging with patients from the comfort of their own home, we provide access to patients who can never be reached by traditional site-based models. We have proven to enroll faster, retain patients at a higher rate, and reach a more representative population. Science 37 has conducted more decentralized, interventional trials than any other company, using an expansive, in-house network of telemedicine investigators and home-health nurses, who are supported by the industry’s most comprehensive, fully integrated, decentralized clinical trial platform. For more information, visit http://www.science37.com/.
Advarra is the premier provider of global research compliance services, including IRB, IBC, consulting, and research technology products. Clinical trial sponsors and CROs recognize Advarra as the largest integrated provider of IRB services with the greatest institutional reach among health systems, cancer centers, academic medical centers, and investigators. Forte, now part of Advarra, is the industry’s leading provider of standards-based research technology, including OnCore CTMS. Advarra optimizes compliance and clinical trials with its robust regulatory expertise and innovative products and services. For more information, visit advarra.com.