Investment key to process and quality improvements in the initialization of clinical trials
SAN FRANCISCO, July 10, 2018 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today that Clinipace has chosen goBalto's end-to-end platform for starting clinical trials.
If you fail to plan, you are planning to fail. These words ring true when it comes to study startup, a notorious bottleneck in clinical trials. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward improving study performance, quality improvement is moving to center stage. With the availability of industry proven workflow-based goBalto Activate, proactive planning, process optimization and quality improvements with study startup – as measured by inspection-readiness and the likelihood of passing regulatory audits – are within reach.
Activate, along with goBalto Analyze, a data analytics platform - optimize the many study startup steps, providing real-time insights into study status, a vast improvement from the manual, time-consuming methods still predominantly used across the industry.
Activate enhances real-time oversight to clinical operations management by tracking milestones on the critical path and providing document management capabilities in a transparent, regulatory-compliant, user-friendly way. Advanced and comprehensive reporting capabilities and real-time insights are provided by Analyze, offering visibility into study startup activities across multiple studies and countries while accommodating proactive interventions and study optimization.
"Activate's robust, industry proven library of country-specific workflows and management-based approach to site activation is central to our efforts to build out our infrastructure of 'best of breed' applications in our eClinical suite," said Mike Townley, CIO, Clinipace. "Using a workflow-based approach to study startup, critical indicators of quality can be assessed on an ongoing basis so that corrective actions, if needed, can be made earlier."
According to Bryan Federowicz, Associate Director, Global Study Start Up and Site Management Services, Clinipace, "Activate's automated workflows direct study team members through the various regulatory and organizational SOP requirements that are both study and country specific, as well as providing role management and alerts for tasks in a queue..." adding, "goBalto sheds light on operational performance by capturing key performance metrics, which are a value add to our predictive analytics."
"Clinipace joins other leading organizations that are committed to modernizing and rethinking how clinical trials are initiated," said Jae Chung, goBalto's President and Founder. “Automation has become critical for reducing the costs and complexities of clinical trials. However, it is not a panacea, rather a catalyst to providing the performance metrics to empower business intelligence, process optimization and efficient resource allocation, thereby improving proactive planning and overall quality in execution."
By ensuring global anytime, anywhere access to purpose-built study startup technology goBalto brings measurable change at the inception of a trial, adoption of which will shorten cycle times, reduce study costs and, most importantly, speed the delivery of new therapies to patients.