Hippocrates's Pharmacovigilance Solution is built on the Aotai Platform, with the Pharmacovigilance System (PVS; VigiTrust®) at its core. It integrates pharmacovigilance processes, pharmacovigilance regulatory databases, pharmacovigilance system documents, industry-specific training materials, quality management systems and management processes, electronic signatures, and other components. As a comprehensive pharmacovigilance solution, it enables enterprises to quickly establish a drug safety business operation system that complies with national regulations and regulatory requirements.
Based on the established VigiTrust® System, the platform's capabilities in signal detection, big data analysis, and business automation can be further enhanced, providing continuous empowerment for pharmaceutical enterprises in conducting pharmacovigilance operations through advanced technologies.
This solution is one of the core solutions of the Aotai Platform independently developed by Hippocrates. The Aotai Platform has built-in configuration tools and can provide a wide range of platform services, including shared services, data security, data bus, compliance services, performance monitoring, and an advanced data architecture.
The core of the drug safety solution is the pharmacovigilance system, which is interconnected with Hippocrates's Document Management System, Training Management System, and Quality Management System (QMS). This forms a comprehensive digital management system solution for drug safety, ensuring business compliance.
It supports batch data import and processing, which can effectively improve the work efficiency of pharmacovigilance personnel. Among its functions, the SAE Assistant enables the entire business process of SAE data collection, automatic report export, multi-party collaboration, remote real-time electronic signature, and archiving.
The system's functional design is guided and reviewed by pharmacovigilance experts, fully complying with industry regulatory requirements of ICH, FDA, EMA, NMPA, and other authorities. It supports international standards such as E2A, E2B(R3), E2C, E2D, and E2E, and implements standard specifications including the MedDRA clinical terminology set, thus fully meeting domestic and international management standards and regulatory requirements.
The system's functions cover the entire process of pharmacovigilance work, with a design that aligns with relevant domestic and international standards and meets regulatory requirements. It has built-in audit trail and query management functions to satisfy enterprises' inspection and audit needs.
It features convenient and fast data collection, supporting both computer and mobile terminals. The collection process is streamlined and guided, making it simple and easy to learn, with permanent data storage. It can generate multi-dimensional reports covering drugs, clinical practices, regions, and patients, enabling comprehensive data analysis by day, week, month, and full cycle. Additionally, it provides real-time data query and rich graphical report presentation functions. It can also quickly generate PSUR & DSUR reports with guided operations and automatic report generation, resulting in short report cycles and high efficiency.
Hippocrates's Drug Safety Solution is an innovative and comprehensive solution that supports the establishment of pharmacovigilance systems and the implementation of full-scale business activities. Its main functions include: entry of Individual Case Safety Reports (ICSRs) into the system; quality control of ICSRs; medical review of ICSRs and preparation of SAE descriptions; preparation of post-marketing key monitoring study protocols; preparation of key monitoring reports; preparation of clinical trial reports; retrieval of adverse events in Chinese and English literature; formulation of risk control/management strategies; and preparation of RCPs/RMPs. Built on the Aotai Platform, the solution integrates pharmacovigilance regulatory databases, pharmacovigilance system documents, industry-specific training materials, quality management systems and management processes, electronic signatures, the SAE Assistant, and other components. As a comprehensive digital pharmacovigilance solution, it helps enterprises quickly build a pharmacovigilance business operation system that complies with national regulations and regulatory requirements.
The Aotai Platform is a digital platform jointly developed by Hippocrates's industry experts and IT experts. With "Quality and Compliance Expert" as its management philosophy and market positioning, it helps enterprises improve their quality and compliance levels, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the market launch of more safe, effective, and high-quality products. The Pharmacovigilance Solution (PVS) is one of the core solutions based on Hippocrates's OwlTrust Platform.
Applications on the Aotai Platform can be customized to meet enterprises' needs for quality systems. The built-in configuration tools already include multiple functions of quality solutions, eliminating the need for customization or programming to implement certain special processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business requirements.
Quality and compliance processes are built on commonly used master data, which only needs to be set up once and can then be used across different modules of the entire system. New processes will automatically reference these data dictionaries, ensuring that enterprises continue to use a "common language" as their quality systems evolve. The characteristics of the technical architecture include: the organizational hierarchy configuration is fully consistent with the company's structure; it supports data aggregation or in-depth viewing of detailed data at any level; and it can restrict access to different organizational nodes in complex hierarchies.
The excellent design of the Aotai Platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The "intelligent loading" of forms minimizes loading time. Frequently used data is cached to maximize network bandwidth utilization. Data is stored in an efficient manner, and the distributed architecture is optimized for server expansion. Standard APIs greatly improve system access efficiency, including: automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, which significantly reduce the risk of missing tasks or approvals. The background task submission and management mode allows users to perform other tasks simultaneously. A standard intermediate service layer is provided to support integration with any third-party system, facilitating data exchange between the Owltrust Platform and other application systems.
Hippocrates's Drug Safety Solution complies with the latest GVP, FDA 21 CFR Part 11, and GAMP5. It supports the collection, processing, analysis, and submission of Individual Case Safety Reports (ICSRs) for drugs, vaccines, and medical devices; supports MedDRA coding of adverse events and online submission of SUSAR reports via Gateway; supports audit trails and query management to meet report quality management requirements; supports the management of annual reports and periodic reports (such as DSURs and PSURs); supports batch import and processing of feedback data; supports multi-product signal management for enterprises; supports literature task configuration, automatic retrieval, and literature report management; and has built-in multiple permission settings to support flexible configuration. This solution helps enterprises build a comprehensive digital drug safety management system.
