Research focused on assessing practices and inefficiencies associated with site selection and activation
SAN FRANCISCO, August 18, 2016 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today the publication of the peer-reviewed article 'Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation' in Applied Clinical Trials, a study conducted in collaboration with the Tufts Center for the Study of Drug Development (CSDD).
Leading biopharmaceutical companies and contract research organizations (CRO) participated in the Study. Its purpose was to gather in-depth information and a more formal understanding of the types of approaches that are used for activities associated with site selection through site activation.
"We are proud to have had an opportunity to sponsor this research into a perpetual bottleneck in clinical trial conduct – study startup," said Sujay Jadhav, goBalto's CEO. "The results of this study are beneficial to Life Science organizations engaged in starting clinical trials, as they examine their study startup process to identify efficiency improvement areas and adoption of technology to address bottlenecks."
"Site selection, activation and engagement are among the greatest challenges that the clinical research enterprise faces today. The study start-up phase is highly inefficient and rich with opportunity for improvement," said Ken Getz, Director of Sponsored Research Programs and an Associate Professor at Tufts CSDD. "The results of the new study provide important insights into improving study initiation efficiency and effectiveness."
On average, companies reported that site selection took on average 3.2 months and ranged from two weeks to six months. The reported average cycle time from site identification to site activation was one year. For the typical multicenter study 70% of sites are repeat and 30% are new sites, but site usage varied based on indication and geographic area (global location) where the study was conducted.
Participating companies reported that many factors contribute to inefficiencies and delays associated with site selection, study startup, and site activation. These factors are discussed in the report as are approaches that organizations are taking to improve study startup performance, including investments in technology solutions and data analytics.
The full report, as well as the Tufts CSDD research report ''START' (Start-up Time and Readiness Tracking) Study' conducted in 2012, are available for download from the goBalto Resource Center, visit www.gobalto.com/resource-center.