Data management

• Rapid CRF design
• Data management plan
• Use of fully validated software and export programs
• 21 CFR part 11 compliant SAS-based DM system ClinPlus 3.21 licensed from DZS Software Solutions
• Efficient database design including CDISC-based data structures
• Review of CRF before data entry
• Double data entry by 2 independent people
• Powerful Query Management of manual and programmed validation checks
• Coding by MedDRA, WHO DDE or other specified dictionary
• Export database in SAS, CDISC or other specified format
• At each stage QC report available to sponsor

Click here for our Data Management brochure.