Data Management

SanaClis data management and biostatistics department provides high-quality services to support the clinical development of drugs and medicinal products through the use of powerful and efficient CDISC certified and regulatory compliant EDC software suite and
services of professional biostatisticians.

Our team delivers top quality data on-time, within budget and helps to avoid delays in the clinical research process. Our expert statisticians work closely with the DM team to meet the needs and objectives of each specific project, providing every time a customised service.

• Database design, eCRF and edit checks setup and validation
• MedDRA/WHODRUG auto-encoding and manual coding
• Query handling/query workflow and data cleaning
• Double data entry for paper based CRF
• Central/local laboratories data support/reconciliation
• EDC WebPRO access for patients
• Full service in case of EDC, including helpdesk
• Blind/open randomisation
• Customised data listings and reports generation
• Data export/data transfer (CDISC standards/datasets for SAS/SPSS)