1. Introduction
With the rapid advancement of science and technology, the internet, 5G, big data, and cloud computing are gradually becoming widespread. Various industries in China are undergoing technological innovations, and the pharmaceutical industry is no exception. In response to the increasing number of clinical research studies and to accelerate the market launch of drugs and devices, various new clinical trial technologies have emerged.
Yimaitong, leveraging its resource and technical advantages, has successively launchedClinical Trial Electronic Data Capture System (EDC), Interactive Web Response System (IWRS), Electronic Patient Reported Outcomes System (EPRO) and other digital systems, providing researchers, research institutions, sponsors, CRO companies, and subjects with a more efficient research experience, empowering clinical research to enhance efficiency and reduce costs.
2. EDC System
The clinical trial EDC system independently developed by Yimaitong over several years has provided data capture and management services for dozens of clinical trial institutions and pharmaceutical companies since its launch, handling hundreds of clinical trial projects and receiving unanimous praise from users. The Yimaitong clinical trial EDC system has the following advantages:
● One-stop clinical trial service: comprehensive services from protocol design, EDC system, subject recruitment, to data organization and statistics, solving all problems from project initiation to final results in clinical trials.
● High cost-effectiveness: Charges are based on the complexity of the CRF forms and the logical verification relationships designed, only charging for eCRF form design costs, with minimal server rental and technical maintenance fees (free within one year), allowing clients to spend the least amount of money for the best technical services.
● Fast eCRF form design process: After clients provide the CRF forms, the eCRF form design can be completed within one to two weeks, especially suitable for clinical trial projects with tight timelines that require quick implementation.
● Integration of numerous technical standards: The system can interface with any third-party system to improve data collection efficiency and accuracy.
● OCR recognition: A unique image upload method allows for quick completion of original data uploads, improving data collection efficiency.
3. Randomization System
In response to industry trends and various project needs for clinical trials, Yimaitong has independently developed a central randomization system that fully complies with trial standards. It has undergone strict testing and validation, capable of implementing various randomization methods such as block randomization and dynamic randomization, while providing real-time notifications and trial operation trace records. It is simple to operate, cost-effective, and offers high cost-performance, enabling researchers to complete RCT studies with minimal costs.
● Simple and easy to use: The randomization system features an intuitive and user-friendly interface, making it easy to complete operations such as random grouping without requiring specialized skills.
● Flexible configuration for multiple scenarios: The randomization system can be flexibly configured according to different trial needs, meeting various complex randomization requirements.
● Data security and traceability: The randomization system employs multiple layers of security measures, such as permission management, data encryption, and backups, ensuring data integrity and confidentiality while fully recording data at each step, ensuring data traceability. This allows researchers to confidently use the central randomization system for experimental design and data management.
4. EPRO System
For different clinical research projects, the system can configure personalized subject visit plans, providing reminders through WeChat service accounts, SMS, and other channels. At the same time, subjects can easily complete follow-up questionnaires via their mobile phones, collecting reliable first-hand data from subjects.
● Complete questionnaires online: Subjects can collect self-reported data in real-time through the Electronic Patient Reported Outcomes system (EPRO) and upload the data to the online data collection center for comprehensive management by researchers, achieving data storage, monitoring, and export.
● Flexible configuration of visit data in the backend: The EPRO backend allows for flexible configuration of data collected during subject visits, including visit names, visit date and time windows, and visit data.
● Integration with EDC system: Through EPRO data collection, confirmed data can be directly pushed to the EDC system.
5. Conclusion
The digital systems created by Yimaitong, includingClinical Trial Electronic Data Capture System (EDC), Interactive Web Response System (IWRS), Electronic Patient Reported Outcomes System (EPRO), combine the latest cutting-edge technologies and comply with national laws and regulations. They have already been applied in multiple clinical research projects, receiving positive feedback from users. The platform’s functional modules are provided as SaaS, allowing for rapid personalized configuration for different clinical research projects, significantly shortening development cycles, reducing cost investment, and improving research efficiency.
This platform aims to convey more medical information to healthcare professionals. The content published on this platform should not replace professional medical guidance in any way and should not be considered as medical advice. If such information is used for purposes beyond understanding medical information, this platform bears no related responsibilities. The platform does not endorse the descriptions and views expressed in the published content. For copyright issues, please contact us, and we will handle it promptly.
Click “Read the Original” for more content