Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts

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Data Management

  • Full-service setup and system operation to complete technology transfer and support the complete lifecycle of the clinical trial
  • EDC system compliant with FDA and European regulations, in particular with 21 CFR Part 11 and GMP Annex 11.
  • SanaClis is an active member of the CDISC organisation
  • Database and data entry screens setup and validation
  • Single or Double Data Entry in case of paper CRF
  • Full service in case of EDC including helpdesk
  • Customized data listings and data report generation
  • Database hosting c/o a data centre
  • CRF design (paper or electronic)
  • SanaClis 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.
  • 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)

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. 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.

  • Database design, eCRF & 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
  • Full service in case of EDC including helpdesk
  • Blind/Open randomization
  • Customized data listings and data report generation
  • Data import/export (PROC CDISC/Datasets for SAS/SPSS)
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