We use OpenClinica and Medidata EDC to collect and manage clinical trial data of subjects. The data format can fully comply with CDISC regulations. Data encoding uses MedDRA, WHODRUG, ICD10, etc., and statisticians use SAS programs to provide all statistical services.
• Statistical Consultation
• Study Experimental Design
• Sample size / Power
• Randomization List
• Interim Statistical Analysis
• DSMB Data Review
• By Subject Listing
• Statistical Analysis Plan Writing
• Blind Reviewing and Pre-analysis Meeting
• Statistical Analysis Programming & Validation
• Statistical analysis results outputs (tables, figures, listings) and interpretations
• Statistical report writing
• Case Report Form (CRF) Development
• Case Report Form User Guide Development
• eCRF Designing and Development for EDC Module
• Data Management Plan & Report Writing
• Database Creating & Validation (EDC、SAS)
• Audit Trail Designing and Maintenance
• Data Double Entry & Databases Comparison
• Data Validation Rules Development
• Data Validation Rules Programming & Validation
• Data Coding
• Data Audit
• Data Cleaning
• Database Locking, Unlocking, & Relocking
• Database Transferring
頂尖生技顧問 