Research on inefficiencies associated with starting clinical trials presented to leading pharma and CRO organizations.
goBalto would like to thank the leading Pharmaceutical and CRO organizations that participated in our spring Study Startup Summit, held in New York City, March 8 - 9.
The summit, a biannual event, explored how goBalto's award winning suite of study startup applications are continuing to evolve to help clinical research professionals transform their existing business processes, including best practices and case studies. Multiple organizations presented about their goBalto implementations, results and key learnings to further enhance study startup optimization. The preliminary results from an in-depth benchmarking study, START (Start-up Time And Readiness Tracking) II, conducted in collaboration with the Tufts Center for the Study of Drug Development (CSDD) were also discussed.
goBalto's CEO, Sujay Jadhav, opened the summit with a keynote address highlighting the industry trends in study startup, growing market adoption by the industry, evolution of goBalto's study startup platform and future technology vision.
"There is a growing need for process optimization, improved site engagement and organizational focus on study startup to combat the on-going complexities associated with globalization and outsourcing of trials."
The Tufts CSDD study is central to understanding how these complexities are playing out in the industry. With over 200 pharmaceutical companies and 80 CROs participating 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," said Jadhav. "Study startup remains a perpetual bottleneck, the results of this study will help identify efficiency improvement areas and adoption of technology to address bottlenecks."
Director of Sponsored Research Programs & Associate Professor
Tufts Center for the Study of Drug Development
"The results of the study capture valuable data characterizing how companies are identifying, selecting and managing both new sites and those they have worked with previously. Most importantly, the results provide insights into opportunities to optimize investigative site engagement and study startup."
On average, companies reported that the site identification process typically takes 3-8 weeks to complete; the site selection process takes 5-8 weeks to complete; and the study startup phase typically takes 15-24 weeks. For the typical multicenter study one out of ten investigative sites fail to be activated with budgeting and contracting named as the top cause for the failure.
Importantly, less than 15 percent of participating companies reported that they are satisfied with their current site identification, selection and study startup process, with many relying substantially on unsophisticated and inconsistent practices. Overall, 73 percent of sponsors and 83 percent of CROs expect that better leveraging tools and software will improve the study startup process.
According to Jadhav, "These results represent the driving force behind the growing adoption of our solutions. Presentations at the summit illustrate the significant impact our solutions have had in delivering tangible operating results. We are the only vendor capable of delivering consistent cycle time savings, and it is this field-tested validation that customers are seeking."
With recent multiple enterprise expansions goBalto now services three of the top 5 CROs and more than two-thirds of the top 20 pharma's, representing over 70 percent of clinical trial sites in phase II & III of the top 25 pharma companies. goBalto has activated over 38,000 sites for use in more than 800 global studies from over 240 unique sponsors, enabling reductions in cycle times of more than 30 percent.
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