Industry leader in clinical study startup releases site selection solution
SAN FRANCISCO, March 31, 2016 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today its release of goBalto Select, for optimizing site selection. With this release, goBalto becomes the first life science software vendor to offer a complete end-to-end platform for starting clinical trials, from site feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget.
The process of finding investigative sites for studies today is impeded by cumbersome and error prone interpretation of pertinent data, which is often dispersed in different formats, databases, and repositories, making it difficult to make easy and timely assessments.
Select goes beyond simple aggregation of site data, providing a data driven approach to weighing selection and performance variables to aid in the identification of sites and target populations ideally suited to studies. Select's integrated workflows allow globally dispersed clinical research teams to collaborate in real-time on the most comprehensive site profiles in the market, having purposely been designed to be compatible with numerous investigator databases and industry portals. Selected sites can then be quickly initiated for studies using goBalto Activate's standard 'out-of-the-box' country specific regulatory business process workflows with goBalto Analyze providing continuous, real-time visibility into study status.
"Increased competition for sites and enrollment issues—determining whether or not specific sites have patients, combined with pressure to enroll patients quickly—has increased the number the non-active, non-enrolling (NANE) sites being activated for clinical trials," said Sujay Jadhav, goBalto's CEO. "With this innovative approach to site selection, Sponsors and CROs will now be able to open sites on time and meet enrollment targets."
According to Beth Harper, president of Clinical Performance Partners, "Despite the plethora of data and information available to us, evidence-based site selection processes still seem to elude us as an industry. Perhaps it is a matter of information overload, or inability to integrate the data from multiple sources, but in my experience teams continue to rely on archaic tools and subjective criteria for selecting sites only to find a significant number of sites fail to enroll."
Increasing protocol complexity (e.g., number of amendments, number of endpoints, eligibility criteria) has created challenges with site feasibility assessments. According to research from Tufts CSDD, nearly 40 percent of all amendments occur before the first study volunteer receives first dose. Select minimizes this impact with integrated workflows to complete all site ID and selection activities, reuse of site profile and previous study data to pre-populate surveys, with built-in workflows to manage CDA, protocol amendments, and site ID survey pre-study visits.
Growth in globalization of clinical trials has also fueled study complexity, leading to a reliance of global affiliates to understand all local processes and approvals, resulting in increased costs and delays. "Select reduces the complexity associated with offshoring by expediting collaboration amongst globally dispersed team members, driving data-based business decisions, transparency, and regulatory compliance," said Jadhav.
Jadhav adding, "We are committed to providing our customers with the functionality they need to accelerate the startup phases of clinical trials—and ultimately making valuable therapies available to patients sooner."