Clinical Research IO, Medidata to collaborate
Clinical Research IO (CRIO), a Cambridge-based technology company that has developed the first e-source system for clinical research sites, will participate in a new eConnect Partner program with Medidata to eliminate redundant and costly data entry.
CRIO's system replaces the paper forms used at many research sites with an interactive web and tablet-based application. Using the system, researchers are able to configure e-source templates, and capture data quickly and accurately. The system's alerts, skip logic, auto-calculations and other quality assurance features address up to 50% of common audit findings, according to a third party review by a noted industry quality expert.
While the system improves data capture at the site, it by itself cannot address another major inefficiency--the need to manually enter the data into electronic data capture systems selected by pharmaceutical sponsors, and the attendant need for sponsors to verify the consistency of data across systems. This "source data verification" process costs the industry as much as $6 billion annually.
To solve this problem, CRIO will collaborate with Medidata, the industry leading global provider of cloud-based solutions for the life sciences industry, by integrating with Medidata Clinical Cloud through the eConnect Partner program. This integration will permit research sites to capture data only once, without having to enter manually into a separate electronic data capture system. It will also eliminate the need for sponsors to "source data verify" for consistency across systems.
"We are delighted to be among the first participants in this important new program for the industry," said Raymond Nomizu, co-founder of CRIO. "With this collaboration, we can deliver the industry the best of both worlds: research sites can use our system to capture data accurately and in a manner consistent with their workflows, while sponsors can eliminate costly and unnecessary quality assurance efforts while simultaneously getting immediate access to data."
"Sites really need a solution that works for them, and CRIO works. It is easy to use, intuitive, and every member of our staff had the same positive reaction when we started to convert to e-source," said David Scott, president and CEO of Palm Beach Research, a major clinical research site in Florida. "With this integration, the value with CRIO and e-source will be even stronger; it can easily save us up to 15% of our staff time, allowing us to focus on recruiting, retention and other value-added activities."
CRIO is an e-source solution for clinical research sites. Since its launch in September, 2016, it has signed up over 30 research sites, and is now deployed on over 20 studies.