IT-based Medical R&D construction
- Time of issue:2021-08-05 16:39:40
Intelligent Laboratory Platform (ILP)
ILP integrates management systems of projects, materials, instruments, archives, biological sample banks and biological analysis experiments, and electronic experimental records, etc.. It uses Internet technology to scientifically and efficiently record and manage laboratory materials, equipment, personnel and other information, so as to effectively avoid problems such as disorder and data statistics errors caused by manual management. It can realize the intelligentization of experimental operation, project operation, and R&D management, and ensure true and reliable experimental data, and worry-free supervision and verification.
Pharmaceutical Research Laboratory Information Management System (PharmLIMS)
PharmLIMS mainly focuses on the business process of pharmaceutical research laboratories and biological testing experiments. It integrates analysis and testing, quality control and comprehensive laboratory management, and integrates laboratory data, personnel, instruments, reagents, documents, projects, users, services, and quality, ELN and other management elements. It can not only meet the needs of open management with projects as the core, customer service or drug research as the purpose, but also meet the information integration and management of process manufacturing enterprises for quality monitoring of the entire production process and laboratory analysis of the quality control department.
Laboratory Information Management System for Drug Metabolism and Pharmacokinetics (PharmLIMS for DMPK)
It is the first highly specialized information management system designed for the workflow of biological analysis laboratories in China, and provides information support for biological data analysis and sample management in the field of drug metabolism and pharmacokinetics research.
It comprehensive covers DMPK business processes, providing timely, accurate and comprehensive information for management. The system complies with the regulatory requirements of NMPA and FDA for GLP/GCP, and solves the management problem that data records are incomplete, difficult to trace, and easy to tamper with.
Intelligent Biobank Information Management System (BioBank)
Biobank refers to the standardized collection and storage of normal or pathological specimens for various studies, including human or animal organs, whole blood, plasma, serum, biological fluids or processed human or animal and plant biological samples (DNA, RNA, protein, etc.), as well as the quality control, information management and application system of informed consent, clinical and pathological treatment, periodical follow-up and other information related to these biological samples.
The Biotank is an information system that supports multi-center platforms. It follows standardized data interaction standards, conforms to the computerized system verification system, and uses bar code recognition and template configuration technologies to conveniently realize the error-free management for the entire life cycle of biological samples, including collection, storage, warehousing, inventory, destruction, monitoring and other processes.
Electronic Lab Notebook (PharmELN)
PharmELN provides laboratory data recording solutions for laboratories. Through the integration of multi-center experimental data, the whole process and results of the experiment are recorded to ensure that the data is true, complete, accurate and timely. Powerful search, data mining and information sharing functions help improve the overall efficiency of the laboratories.
Intelligent Clinical Platform (ICP)
The ICP platform focuses on providing one-stop solutions for the informatization of the entire clinical trial process, supports various types of trials such as BE, Phase I-IV, and post-marketing re-evaluation, focuses on the subjects, progress, quality, data, documents, drugs and other content in the clinical research process, and realizes the online collaborative office of sponsors, clinical research institutions, ethics committees, CROs, SMOs, etc. By advanced technologies such as big data, cloud computing, sensor technology, and blockchain, the platform breaks data flow barriers, effectively improves the quality and efficiency of clinical research, shortens the drug development cycle, reduces research and development risks and costs, and ensures that the data is true and traceable, so as to support drug clinical research.
Ethical review cloud platform (YooTrial ETHICS)
YooTrial ETHICS is designed in accordance with the requirements of ethical review regulations to ensure the compliance of each business link, and on this premise, it supports certain flexibility of procedures to ensure the quality of ethical review. The system covers the entire business process of ethical review, and realizes the information management of the entire process of ethical review, including application, acceptance, review, decision communication, and document archiving. At each key node of the business, it will proactively notify the responsible persons through system messages, short messages, etc., to improve work efficiency and simplify management processes.
Phase I clinical research management system (YooTrial Capture)
The Phase I data management system (YooTrial Capture) is a professional software used for the entire process of informatization data collection on the clinical trial site. It adopts advanced technologies such as biometrics and sensor technology to make the data collected on site more timely, more real, more accurate, more complete, and traceable throughout the operation, ensuring legal and regulatory compliance, high efficiency and high quality of clinical research.
Clinical Trial project Management System (YooTrial CTMS)
YooTrial CTMS is a multi-center collaborative clinical trial project management cloud platform. It is designed based on the concept of ensuring quality and improving efficiency. It follows GCP, ICH GCP, 21 CFR Part 11, GAMP, CDISC and other laws, regulations and industry standards, and connects institutions, ethics committees, sponsors, CROs and other clinical trial participants, so as to facilitate communication with related staff in a task-driven manner and significantly improve the efficiency of project management.
The system can manage the entire process of clinical trial projects, including approval, ethical review, contract signing, drugs, subjects, supervision, inspection, follow-up, and conclusion, supports the seamless connection to central randomization system, ethical review management system, EDC, etc., and realizes the data intercommunication of each system. The system focuses on user experience and knowledge accumulation of management experience, and transfers the effective experience of progress management, document management, approval process management, and authority management in the process of clinical trial projects into various templates, so as to continuously improve project management methods and optimize management means.
Subject intelligent authentication management system (YooTrial Auth)
YooTrial Auth is composed of a multi-dimensional intelligent authentication instrument and a subject trial information management authentication and duplicate checking system. Through integrated innovation and national network management model, the subjects in the clinical trial process are accurately managed, and the authentication accuracy rate reaches 99.999%.
The system completely solves a series of industry pain points such as the false identity of subjects, the single source of institutional information, and the lack of regulatory means by the government, and changes the history of subject management in drug clinical trials.
Electronic Data Collection system (YooTrial EDC)
YooTrial EDC adopts the latest micro-service concept to provide transparent and accurate data management for the entire clinical research process. It has functions of visualized fast database construction, powerful logical verification, and convenient data collection, so as to realize real-time data collection and comprehensive management.
The entire process from data generation to export is traceable, so as to ensure that the data is absolutely true and reliable. It is an efficient and compliant new generation of cloud EDC system.
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