DaS EDC
- According to GAMP5 system verification, the system is safe and reliable
- Complies with the electronic signature requirements of FDA 21 CFR Part 11
- Complies with regulations such as ICH GCP and NMPA
- Flexible database structure to meet different clinical trial requirements
- Multilingual version, supporting global multicenter clinical research development
- Highest standard IDC computer room in China for remote backup to ensure data security
- Strong technical team develops the system; Operation and Maintenance Engineer 7 × 24-hour rapid response, providing professional technical support.
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Efficient and Easy to use
Humanized interface UI layout and functional design, enabling quick and precise switching of various modules, reducing user usage costs and improving efficiency;
Standardized
Provide standardized data reports and manage team data from different dimensions; Support CDISC standard ODM.xml import and export.
Flexible
Support site, subject, visit, form, and field level operation, reduce repetitive system operations;
Platformized
Platform integration management module for research creation, research center management, coding configuration, and data sharing settings;
Translation Workbench
Support configuration and subject data translation, and provide a complete solution for data translation
Online or offline translation selection; Translation and proofreading process ensures data accuracy
Data Standardization
Support ODM.xml import and export of CIDSC standard
System API for data exchange between different supplier systems; Including Subject data and Admin data, perform database configuration reading and updating based on Admin data
Rich applied Experience
- More than 3000 clinical trials have been conducted using DaS EDC for data collection and management, covering Phase I-IV new drug registration and national research projects, applied to various indications.
- More than 500000 subjects were collected and applied to many national major special researches, such as AIDS prevention and treatment, HPV database; Support the Shanghai three-year action plan database platform.
- DaS EDC has been used in over 800 hospitals/institutions, covering the entire china (including Hong Kong and Taiwan).
- Serving over 600 enterprises and research institutions, and also participating in international multi center experiments, with rich experience.