Get to know the steps and bottlenecks when starting a clinical study
SAN FRANCISCO, November 2, 2017 -- goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced todaythe latest release of its popular eBook '10 Steps to Clinical Study Startup.' Since its inaugural release, the eBook has been downloaded over 62,000 times.
Clinical trials that get off to a good start are more likely to be successful trials. The study startup (SSU) phase is where this happens, and includes such activities as investigator selection, regulatory and ethics submissions, site trainings and ends with the site initiation visits. SSU is a time-consuming component of a clinical study, a notorious bottleneck, that can contribute to significant delays due to manual and old-school paper-based processes, requiring multiple approvals and hand-offs between sponsor and sites, as well as, between individual team members both at the site and within/between the sponsor, which makes the process a perfect candidate for optimization.
But what exactly happens in the SSU phase and how can it be improved? Through years of dialogue with sponsors, contract research organizations (CRO) and sites, we've identified 10 key steps that clinical trial sponsors take to select sites and activate them for a clinical study. Further, we’ve pinpointed where the SSU process fails and how to optimize each of these steps so that you can gain a competitive advantage in new drug development.
"We are proud to have partnered with numerous thought leaders in the industry in the creation of this latest update," said Jae Chung, goBalto's Founder and President. "Examining all of the steps and pitfalls of study startup it's easy to see why all too often, study startup does not end even as the study progresses through conduct."
This eBook will take you step-by-step through SSU. The 10 steps are comprehensive and typical of the study startup process in the United States; however, you may find that the order of the steps vary from company-to-company and study-to-study.
Chung added, "Better managing clinical study startup represents a substantial opportunity for sponsors to reduce clinical study timelines, and costs, enabling therapies to get to those in need faster."
The eBook is available for download from the goBalto Resource Center, visit www.gobalto.com/resource-center.