With an industry average of 12 weeks, it’s incredible that we were able to enable Cytovale, Inc. to achieve their first patient in (FPI) in just seven days. The Cytovale technology will allow patients with sepsis to be identified earlier in their hospital stay.
In a time where speed is of the utmost importance, Medrio supported Study Builders, LLC to build the study and Cytovale to begin enrolling patients in the study in just seven days. The study concept was presented on March 26, 2020, with FPI achieved on April 7, 2020.
“We initially scoped 12 weeks to FPI for this very complex study. With Medrio’s easy configuration interface and attentive support team and Cytovale’s dedicated UAT team, we were able to aggressively build and have the study ready for data entry in just 7 days. I’ve worked with Medrio on a number of studies, and on average we typically achieve FPI in six to eight weeks, some in as little as two or three weeks, but 7 days is a real achievement,” said Temple Herlong, Managing Member, Study Builders, LLC.
“We’re faced with an unprecedented challenge in the time of COVID-19, but our collective determination and expertise enabled us to execute. Detecting sepsis early is imperative for effective treatment and would enable the clinical team to ensure that the right patient receives the right level of care at a time when resources are stretched and every moment counts. Achieving FPI in only seven days is a huge feat, and all parties involved should be extremely proud of their efforts,” said Ajay Shah, Ph.D., Co-founder, and CEO of Cytovale.
A typical study with Medirio can get FPI within 6 weeks compared to the industry average of 12 weeks, due to the programming free drag and drop interface of our EDC system. Speed coupled with a flexible system puts you in the driver’s seat allowing changes on your timeline without coding or extra fees. From ICH/GCP and 21 CFR to GDPR and HIPAA, our customers are equipped with easy-to-use tools allowing them to focus on the trial with complete confidence that their data is compliant and secure. As organizations transition to more virtual operations, our hybrid and decentralized solutions are ready to help you meet accelerated timelines and changes when you need them.
In addition to our EDC, we offer ePRO, eConsent, and Direct Capture as an integrated system. Discover how to accelerate your trials and reduce risk with adaptable technology and services built for easy mid-study changes and real-time data monitoring – sign up for your personalized demo.