High-quality data management and statistics are the key part of clinical research. The Clinical Research Public Technical Service Platform is a strong supporting system for drug development and the clinical assessment of new drugs. To provide computerized system to manage clinical data and the whole process involved in clinical studies and help to improve the data accuracy and efficiency, SCRC initiatively developed a Clinical Research Integrated Solution (CRIS) with intellectual property right that complies with ICH-GCP guidelines and technical standards.
CRIS provides a series of professional tool software systems to help users at affordable cost and a minimal risk establish and implement an electronic clinical trial management system that confirms to international standards. This platform adopts modularization design, where each module can either operate independently or freely combine, to maximally satisfy the users’ business needs. These modules include
- Data Management
- Multi-Center Randomization
- LIMS System Data Exchange
- Pharmaceutical Administration
- Project Progress Management
- Ethnic Review Management
- Document Management
- Budget and Finance Management
- CRA Management and so on.
CRIS adopts the mode of SaaS (software as a service) to provide high-quality services for the users. They needn’t buy hardware or configure IT maintenance personnel, instead, they need only to “rent” corresponding module and services according to their own individual business needs.
The developing of the clinical trial data management system (version 2.0) completely observed CDISC norms, with ODM as the data model of the system and SDTM as the data exchange standard. The system is compatible with the traditional written-form CRF procedure and electrical CRF procedure, thus providing solutions to business transition for the users.
The clinical trial data management system (version 2.0) comprehensively covers the whole procedure of data management, including the definition of CRF design and database, the definitions of various calibration rules, CRF management, data entry and cleaning, data lock-in and export, etc. For the present, this system has been promoted and tried out in the clinical trial sites of many hospitals in Shanghai and Beijing and CRO companies as well.