Our comprehensive solution revolutionizes the clinical research document lifecycle, enhancing the entire process from the inception of the "Protocol" to the crucial submission of essential documents like the "CSR" during drug registration.
Challenges of traditional document writing
and management methods
Efficiency and quality control of document drafting
Compliance challenges in document management
Ethical risks of document information leakage
Our solution brings customer
High-quality and professional document content recommendations for drafting
Secure and compliant document management processes and methods
End-to-end document and data flow throughout the entire lifecycle
Customer A, a leading domestic pharmaceutical company, has been unable to solve the following issues for many years
With limited human resources, hundreds of clinical research documents need to be completed every year, making it difficult to maintain quality under heavy workloads.
Clinical research document management relies more on personal local and cloud storage, making it impossible to standardize enterprise-level management.
The review and inspection of upstream clinical research documents cannot be efficiently associated with the writing or generation of downstream documents, resulting in costly utilization of Human Resources being used for tasks such as comparison and copy-pasting.
AuroraPrime's end-to-end solution for clinical research documentation addresses the customer's actual problems and provides the following features at the system level to optimize user experience and meet practical management needs:
Intelligent Content Recommendation
Prime Create, an intelligent clinical research document writing system, offers professional content recommendations, facilitating the identification of highly relevant and valuable content (e.g., protocols). This enhances document production efficiency, quality, and cost-effectiveness by reducing human resource requirements.
Enterprise-level Document Management
Prime Catalog, a comprehensive clinical research document management system, combines regulatory compliant eTMF functionality with intelligent automation. It empowers enterprises to efficiently manage documents at scale throughout their lifecycle.
Accelerated CSR Generation
Prime Create, an intelligent clinical research document writing system, offers automatic associations between upstream and downstream documents. When writing CSR, users only need to focus on confirming and adjusting the system's automatic content references (e.g., protocols and TFLs). This significantly reduces unnecessary time and labor costs.
Thanks to AuroraPrime's solutions, Customer A has significantly improved clinical document management efficiency by more than 70%, reduced the average time for various clinical research document drafting by over 50%, and decreased the document quality rework rate to less than 5%. This has provided more efficient guarantees for internal and external team collaboration and enterprise-level management.
The end-to-end solution for clinical research documentation of AuroraPrime has helped us overcome many challenges faced by management, medical writing team, and quality control team in dealing with a large number of clinical documents during the initial drafting, revision, finalization, and archiving stages. This has greatly improved the efficiency and quality of document and data transfer throughout the process.