Service offered :-

• Study design (including adaptive study designs) / protocol development / consulting
• Sample size calculations
• Simulation studies
• Randomisation schemes
• Statistical Analysis Plans (SAP)
• Designing statistical tables, data listings and figures for clinical studyreports
• Programming statistical tables, data listings and figures for clinicalstudy reports
• Regulatory guidance, planning, and meeting representation
• end-to-end data management solutions
• customized solutions to varying needs of client
• designing of CRF to data base lock services

• CRF vs CDISC/SEND perspective
• ECRF and paper-based CRF design as per CDASH standards of CDISC
• SOP changes, redesigning, companywide training of new processes/changes
• Database Design and Programming
• Edit check programming, validation, and testing
• Data management plan development
• CRF completion guidelines
• Data entry and processing (First Pass, Second Pass)
• Data cleaning and validation
• Medical coding
• Integration of external data
• SAE reconciliations
• Data Export
• Database Lock and Archival