goBalto Joins The Avoca Quality Consortium

goBalto has announced 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."

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