Industry leader in clinical study startup leverages metrics driven approach to deliver operational performance
SAN FRANCISCO, March 8, 2016 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today its partnership with the Metrics Champion Consortium (MCC) as they join MCC's Leadership program. As a member of the Leadership Group, goBalto and the Metrics Champion Consortium member organizations will collaborate to define industry benchmark measures for Life Science organizations engaged in starting clinical trials.
According to the Tufts Center for the Study of Drug Development (CSDD), it takes eight months to advance from the pre-visit phase through site initiation, which prepares the site for conducting the study. Moreover, the mean clinical development time is lengthy, an estimated 6.7 years, translating into lost revenue in the range of $600,000 - $8M per day because a drug is not yet on the market.
"Current thinking looks to an improved Study Startup (SSU) process as holding great promise for accelerating clinical trials," said Sujay Jadhav, goBalto's CEO.
SSU refers to a series of steps performed before a clinical trial begins. These typically include activities such as country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget negotiations, and enrolling the first patient. Since each of these steps has multiple components, delays in study timelines are commonplace.
"Benchmarking is a critical step in the identification of potential risks, risks which could result in timeline delays, cost overruns, derailment, or a study necessitating a rescue. Decisions for risk mitigation are best made using data-driven evidence, so that timely interventions can be made," added Jadhav. "We are proud to partner with MCC on helping to define SSU metrics that can be adopted by all Life Science organizations engaged in starting clinical trials."
Considered the gold standard when it comes to standardized performance metrics across the clinical space, MCC is an industry consortium organization that drives clinical data improvements through the collaborative use of performance metrics. They identify what to measure in clinical trials and how to assess the data on a consistently evolving basis.
"goBalto has the metrics driven knowledge and functional expertise to be a key source of support and insight in the community," said Linda Sullivan, co-founder and president of MCC. "Their extensive industry experience will aid MCC in the development of standard definitions and performance baselines for cycle time metrics associated with study startup activities."
With recent multiple enterprise expansions goBalto now services more than three-quarters of the top global pharma's and CROs. goBalto has the largest industry-proven set of country specific regulatory business process workflows and associated in-depth activation metrics.
According to Jadhav, "We share a common vision of making life saving therapies available to patients sooner, and our partnership represents an important step towards the realization of that goal."
About MCC LLC
The mission of the Metrics Champion Consortium LLC (MCC LLC) is to help sponsor and service provider organizations involved in biopharmaceutical and device R&D improve development time, cost, and quality through continuous collaborative development and implementation of standardized performance metrics and process improvement tools, membership education and communication. The management team consists of co-founder & president, Linda Sullivan and owners and advisors, Ken Getz and Dave Zuckerman. For more information, visit metricschampion.org.
goBalto is the industry leader in cloud-based study startup software for the global life sciences industry. Committed to accelerating clinical trials through innovation, product excellence, and customer success, goBalto works with over half of top 20 Pharma and top 10 CROs. Our customers include: Novartis, Genentech Roche, ICON, INC Research and Covance. goBalto is headquartered in San Francisco, with offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.