Focus on operational efficiencies and effectiveness key to tackling entrenched study startup bottlenecks
SAN FRANCISCO, January 16, 2018 -- goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced today its membership in The Avoca Quality Consortium (AQC), a collaborative focused on quality management in clinical outsourcing.
With the advent of the ICH E6 (R2) addendum, quality, oversight and risk management are spotlight areas of interest for pharmaceutical and biotech companies. Both goBalto and the AQC are focused on providing relevant leading practices and metrics to ensure these issues are addressed head-on by proactive planning into the initiation of clinical trials in order to stem downstream organizational non-compliance and related issues which can derail a study.
Study startup is an array of activities performed at the outset of studies, including: investigative site selection and initiation, regulatory document submission, contract and budget negotiations, and enrolling the first subject. The process of initiating clinical trials remains unwieldy, challenging, and often behind schedule, making study startup one of the poorest performing aspects of clinical trials. At a time when study startup remains a perpetual bottleneck, leading companies are positioning themselves ahead of the curve by embracing solutions that confront these real challenges, thereby emphasizing differentiation and operational efficiencies.
"We are proud to contribute to the Avoca Quality Consortium, an organization recognized by many of our clients in supporting their goals of achieving clinical trial excellence," said Sujay Jadhav, goBalto's CEO. "We look forward to providing members with key insights and best practices on industry issues, such as outsourcing oversight, compliance, risk management, and quality associated with starting studies."
"Avoca and goBalto are committed to accelerating clinical trials by process optimization in clinical trial execution," said Patricia Leuchten, President and CEO, The Avoca Group. "We welcome goBalto as a new AQC Member and look forward to working together as part of our collaboration model to further both quality and compliance initiatives."
goBalto is the only life science vendor to offer a complete end-to-end platform for starting clinical trials, from site identification, feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget.
With over 300 pharma and CRO companies benefiting through a networked model using Activate to manage, track, and complete study startup tasks in over 2,000 studies, utilizing over 70,000 sites, in 70+ countries, goBalto has the largest industry-proven set of country workflows and associated performance metrics. Standard 'out-of-the-box' country specific regulatory business process workflows allow for quick site activation, leading to greater cost savings and faster market entry, making valuable therapies available to patients sooner.