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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
