Hippocrates Clinical Research Solutions: OwlTrust® Series Systems Fully Empower Clinical Trials

In the field of pharmaceutical R&D, rigorous, efficient, and compliant clinical research is crucial for the successful launch of drugs. Hippocrates has launched its clinical research solution – the OwlTrust® Series Systems (including EDC System and IWRS Central Randomization System). Relying on its advanced technical architecture, comprehensive functional coverage, and strict compliance, it provides a one-stop digital management platform for global clinical trials. The following is an introduction from the dimensions of technical standards, core functions, data analysis, and product highlights.

I. Technical Platform: Adhering Strictly to International Standards and Forging a Solid Foundation for Security

Guided by the core design concept of international compliance, the technical platform of Hippocrates’s clinical research solution has obtained multiple authoritative certifications and standard adaptations:

• Quality Management System: Certified by ISO9001 (Quality Management), ISO20000 (IT Service Management), and ISO27001 (Information Security Management), ensuring the standardization of the system’s full-life-cycle management and data security.
• Industry Data Standards: Supports ICH E2B (Pharmaceutical Adverse Reaction Reporting) and CDISC (Clinical Data Interchange Standards Consortium) data standards, and is compatible with the MedDRA medical coding system, meeting the data interoperability and regulatory requirements of global multi-center clinical trials.
• System Validation System: Obtained GAMP5 (Good Automated Manufacturing Practice) system validation, ensuring the reliability and traceability of the system in clinical trial scenarios.

II. Solution Features: OwlTrust® EDC System – End-to-End Data Management to Drive Precise and Efficient Research

(I) Data Collection and Management: Full-Cycle Coverage to Ensure Data Quality

• Intelligent Database Construction and Data Entry: Automatically constructs databases based on the eCRF template library, supports the entry, editing, quality control, deletion, query, and statistics of research data, enables standardized data export, and seamlessly connects with pharmacovigilance systems, covering the entire data management process.
• Full-Life-Cycle Management of Subjects: Supports operations such as adding, editing, and deleting subject information, as well as reviewing, freezing, locking, and signing, ensuring the integrity of subject data and operational compliance.
• Project and User Management: Allows users to flexibly manage project information and member permissions. After a project is locked, data can only be viewed and exported, ensuring the stability of data status.

(II) Quality Management: Multiple Mechanisms to Ensure Data Reliability

• Electronic Signature and Medical Review: The electronic signature function enhances the legal validity of data, while the medical review function ensures the medical accuracy of data through professional teams. These two mechanisms jointly improve the quality control level.
• Intelligent Coding and Logical Verification: Integrates international medical dictionaries (e.g., MedDRA) and an intelligent coding environment, and supports custom synonym libraries; reduces human errors through real-time logical verification and data standardization.
• Query Management and Audit Trail: Provides detailed audit trail records and query management functions, enabling tracking of data change history and management of query items, ensuring data transparency and traceability.

(III) Multi-Dimensional Data Analysis: Real-Time Monitoring to Support Scientific Decision-Making

• Project and Subject Status Analysis: Offers project progress statistics and subject status statistics functions to help managers grasp the trial progress in real time.
• Data Status and Query Analysis: Conducts statistics on data signature, review, freezing, and locking statuses, and analyzes the number of queries and response situations, intuitively reflecting data quality.
• Data Completion and SDV Analysis: Displays data completion rate and Source Data Verification (SDV) status, providing key indicators for project quality evaluation.

III. Solution Value: OwlTrust® IWRS Central Randomization System – Intelligent Randomization and Drug Management to Optimize Trial Processes

(I) Randomization Scheme: Flexible and Accurate to Adapt to Diverse Needs

• Supports multiple randomization methods such as static randomization (block randomization) and dynamic randomization (minimization, variance method), meeting the statistical requirements of different trial designs and ensuring the scientificity of group allocation.

(II) End-to-End Drug Management: Intelligent Leadership to Ensure Supply Security

• Demand Forecasting and Inventory Management: Predicts drug demand through intelligent algorithms, avoiding inventory overstock or shortage and ensuring the continuity of drug use.
• Expiration Date Alert and Logistics Tracking: Monitors drug expiration dates in real time and connects to logistics platforms to realize real-time tracking of delivery trajectories, ensuring full traceability of the drug circulation process.

(III) Real-Time Monitoring and Risk Mitigation: Patent Technology Guards Trial Quality

• Relies on independent patent technology to monitor trial progress in real time, promptly alerts and feeds back abnormal data or operations, reduces the risk of randomization errors, and maintains data accuracy and trial compliance.

IV. Core Product Highlights: Six Advantages Driving Innovation in Clinical Trials

1. Leading Compliance: Strictly complies with international standards and regulations, adapting to the regulatory requirements of global multi-center trials.
2. Comprehensive Functional Coverage: Integrates full-process modules such as data collection, management, quality control, analysis, randomization, and drug management, meeting the full-cycle needs of clinical trials.
3. Flexible eCRF Structure: Supports custom form design to adapt to the personalized needs of different disease fields and trial protocols.
4. Intelligent Medical Coding: Reduces manual coding costs and improves the efficiency and accuracy of data standardization.
5. Data Security Assurance: Ensures data storage and transmission security through ISO27001 certification and multiple encryption technologies.
6. Optimized User Experience: Features a user-friendly interface, multi-language support, and real-time data integration functions, lowering the threshold for use and improving research efficiency.

V. Why Choose Singerdi: Professional Empowerment for Cost Reduction and Efficiency Enhancement

Hippocrates’s clinical research solutions not only provide technologically advanced digital tools but also rely on a professional team to offer full-cycle technical support, helping clients reduce trial costs and shorten research cycles. Whether for early-phase clinical trials or complex Phase III studies, the OwlTrust® Series Systems can serve as a reliable partner for global pharmaceutical companies and research institutions with their compliance, intelligence, and efficiency.