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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
