CSIA Services
Data management
US-IND compliant service with high speed services at high quality from our well–experiences expertise
CSIA provides a full support DM service with reasonable price with CTMS, and CDISC compliant CDMS (OpenClinica) or EDC (eClinicalOS, Inform, Viedoc）, Medical Coding (MedDRA, WHO-DDs and IDF), Medical Review and provide the service along with the customer needs, and tender care as equal service compared to the big global CRO to launch the customer’s developing product.
Services
- Design of paper-based CRF / eCRF
- Randomization Schedules & Implementation
- Preparation of the procedure documents related to DM including data management plan (DMP)
- System construction of Clinical Data Management System (CDMS) or Electronic data capture (EDC) including User Acceptance Test
- Preparation of Data Validation Specification
Data Cleaning
- CRF data entry (double entry) (only for paper-based CRF)
- CRF cleaning (data validation) / query management
- Identification of violated cases from protocol, and preparation of all sorts of lists
- Medical coding (MedDRA, WHO–DDs, IDF, etc.) and Medical Review
- Preparation of documents for review committee
- Preparation of Study Data Tabulation Model (SDTM) Mapping specification
- Construction and validation of program for SDTM
- Construction and validation of data for SDTM (OpenCDISC)
- Database lock
- Preparation of data management report
- Preparation of Define-XML & Study Data Reviewer’s guide (SDRG)