First-of-Its-Kind Benchmark Study on Investigative Site Initiation Process Published in Therapeutic Innovation & Regulatory Science
SAN FRANCISCO, Jan. 15, 2013 /PRNewswire/ -- goBalto, Inc. announced today the publication of 'Benchmarking the Study Initiation Process' in the January 2013 issue of the Therapeutic Innovation & Regulatory Science journal (formally called the 'Drug Information Journal' published by DIA), a study conducted in collaboration with the Tufts Center for the Study of Drug Development (CSDD).
The benchmarking initiative, known as the START (Startup Time And Readiness Tracking) study, required the participation of 11 top biopharmaceutical companies. These companies contributed detailed study startup data from more than 100 clinical trials and more than 5,000 global investigative sites. The purpose of the study was to perform a retrospective quantitative analysis of the study startup process to identify efficiency improvement areas and inform clinical trial management decision-making.
"We are proud to have had the opportunity to sponsor this worthy endeavor in benchmarking study startup," said Jae Chung, Founder and CEO of goBalto, Inc. "The results of this study are of potential benefit to organizations as they examine their study initiation cycle times and milestones."
"The study start-up phase is highly inefficient and rich with opportunity for improvement," said Ken Getz, Director of Sponsored Research Programs at Tufts CSDD. "The results of the START study summarized in the manuscript offer important insights into areas of leverage in improving study initiation speed and efficiency."
About Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group at Tufts University in Boston, Massachusetts. Our mission is to develop strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical and biopharmaceutical development, review, and utilization. Our path-breaking research informs the research-based industry, regulatory agencies, and the public about the nature and pace of pharmaceutical development
goBalto develops next-generation, cloud-based solutions that simplify how clinical trials are conducted in the pharmaceutical, biotechnology, and medical device industries. Our flagship product, Tracker, is a purpose-built software-as-a-service clinical research tool. It enables clinical trial sponsors and research organizations to track and collaborate on operational data in a transparent, regulatory-compliant, and user-friendly way. Founded in 2008 in Silicon Valley by biotechnology industry veteran Jae Chung, goBalto is backed by leading health technology investors. For more information, visit www.gobalto.com.
SOURCE goBalto, Inc.