goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced its partnership with the Metrics Champion Consortium (MCC) as they join MCC's Leadership programme. As a member of the Leadership Group, goBalto and the Metrics Champion Consortium member organisations will collaborate to define industry benchmark measures for Life Science organisations 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 organisations engaged in starting clinical trials."
Considered the gold standard when it comes to standardised 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."