Benefit From Faster Study Startup with Expert Support
We provide highly professional, rapid, and exacting clinical data management services. Our Data Management has a track record of handling 1,000+ projects. Our experienced staff assure the reliability of your study’s data, in accordance to Good Clinical Practice (GCP), Good Post-marketing Study Practice (GPSP) and other related regulations. We support product development from clinical studies to post-marketing surveillance.
CMIC provides global coverage for data management services, with offices in Japan, South Korea, and Vietnam.
Our Edge in Data Management
Services with high-added value and quality
- We provide large scale operations in data management center (for example, monitoring over 20,000 cases for one project).
- Work specifications are built by CDISC-trained staff for SDTM data conversion.
- We provide services with added high quality and value.
Services
Data Management Services and Electronic Data Capture (EDC)
- Data management plan, procedures creation
- eCRF screen designing, structuring support
- Database specification creation (pCRF trial)
- Database construction (Audit trail system applied, pCRF trial）
- Data validation specification designing and edit check structuring support
- Data entry guideline creation
- User training conduct
- Management of sites’ users and employees
- Status control for trials
- Data entry (pCRF trial)
- Computerized-programmed check
- Manual check conduct
- Query management (Creation, sending, and closing）
- Data clarification form (DCF) creation (pCRF trial)
- External data import management (Regular import completion confirmation)
- Lab data from central lab, e-Diary, IVRS data and EDC data integration with confirmation on consistency
- Coding activity for safety and concomitant medication data collected by EDC
- Management and transfer for EDC-collected-SAE information
- Output creation for case examination
- Data management report creation
