goBalto Completes a Successful FDA 21 CFR Part 11 Compliance Audit
goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit of its goBalto Tracker™ Software-as-a-Service (SaaS) clinical trials application. Tracker's successful audit will help both sponsors/clinical research organizations and investigator sites running clinical trials comply with FDA rules and regulations governing electronic records and electronic signatures.
"The Tracker application demonstrated compliance with the current 21 CFR Part 11 industry standards feature set for security, data transfer, audit trails, and electronic signatures. No deficiencies were found. The implementation of security and electronic signature components is elegant and sets a new standard for web-based GxP applications," said David Nettleton, principal at Computer System Validation, who conducted the audit.
goBalto and David Nettleton found innovative ways to balance 21 CFR Part 11 compliance requirements with cutting-edge Agile software development practices, facilitating rapid response from the feedback of clinical trial professionals.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
