Anova Enterprises, Inc., a technology-enabled contract research organization, has launched a global clinical registry designed to accelerate the development of promising new treatments and improve patient access to clinical trials. The 21 CFR Part 11 compliant AnovaOS® global clinical registry provides a comprehensive source of real-world evidence about research sites and patients, offering administrative efficiency and supporting faster go-to-market timelines for pharmaceutical sponsors.
Platform Capabilities and Global Reach
The AnovaOS® Software-as-a-Service solution enables clinical trial sponsors to connect with over 60,000 research-ready clinical research sites globally. The platform streamlines access for research participants, accelerates throughput of new therapies, and provides a framework for collaboration, quality evidence generation, and scientific insight. Research sites are increasingly utilizing the platform to identify clinical trial opportunities for their patients.
Advanced Data Collection and Control Group Sharing
New functionality within the registry enables registry-quality data collection and provides capabilities to support real-world-evidence studies, sharing of study control groups across studies, identification of highly-refined patient populations, and collection of quality data for compassionate use pathways. This approach has the potential to significantly reduce development costs and timelines.
The platform offers practical applications across therapeutic areas. For example, registry-quality data collected from the care of children with brain tumors can be used to compare against data on how patients receiving a new investigational drug are performing, potentially demonstrating treatment efficacy and supporting marketing approval applications. Additionally, companies developing drugs in the same indication can share the same control group, reducing costs and accelerating study conduct while decreasing the number of patients required to receive less effective treatments in clinical trial control groups.
Industry Context and Leadership Perspective
"The launch of Anova's global clinical registry comes at a time when the life sciences industry is increasingly turning to global, data-driven solutions to accelerate innovation," said Martin Walsh, President and Co-Founder at Anova. "The global clinical registry will be available to clinical trial sponsors, academic researchers, and healthcare partners, with strong safeguards in place to ensure patient privacy and compliance with global data protection regulations."
Supporting Regulatory and Post-Market Activities
The registry's quality data can be utilized to support post-market surveillance programs, data-driven study design, and marketing approvals. This comprehensive approach addresses multiple phases of drug development, from initial clinical trials through post-market monitoring, providing a continuous source of real-world evidence to inform clinical decision-making throughout the product lifecycle.
The platform represents Anova's commitment to improving clinical trial conduct through its proprietary technology, particularly focusing on accelerating clinical development for start-up biopharmaceutical companies. The global clinical registry is available to clinical trial sponsors, academic researchers, and healthcare partners, with robust data protection measures ensuring compliance with international regulations.
