DATA MANAGEMENT

SanaClis is an active member of the CDISC organization. SanaClis Data Management & Biostatistics department provide high quality services to support the clinical development of drugs and medical products through the use of powerful and efficient CDISC Certified & regulatory compliant EDC software suite and services of professional biostatisticians. We provide full-service setup and system operation to complete technology transfer and support the complete lifecycle of the clinical trial. 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 customized service.

EDC system

  • SanaClis EDC system is compliant with FDA and European regulations, in particular with 21 CFR Part 11 and GMP Annex 11. Our EDC system supports multi-language eCRFs, full integration of all kinds of external data (graphics, CT assessments, X-rays, etc), e-signatures, clickable anatomical images, concomitant medication documentation, online and PDF reports. We provide also full service in case of EDC including helpdesk.

IWRS

  • Interactive Web Response System supports open or double-blind randomization, multiple patients groups, randomization based on block list or minimization algorithm, IMP accountability modules

Our Data Management & Biostatistics department can also provide you with:

  • Database design, eCRF & edit checks setup and validation
  • Database and data entry screens setup and validation
  • Data warehousing
  • Query Handling/ Query Workflow and Data Cleaning
  • Customized data listings and data report generation
  • Interim and final biostatistical analysis
  • Database hosting c/o a data centre
  • MedDRA/WHO DDE auto-encoding and manual coding
  • Blind/Open randomization
  • Data import/export (PROC CDISC/Datasets for SAS/SPSS)
  • CDISC standardization