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Data Management
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High-quality and reliable data for statistical analysis for use in clinical trials

 

Data Management: Quality & Technology Hand in Hand

Our extensive team of Data Management experts around the world, are using the latest data management integration systems to obtain and harvest the very highest quality of Data. SanaClis Data Management Department provides full-service setup and system operation to complete technology transfer to fully support the complete lifecycle of the clinical trial. 

Our Data Management services include:

  • Protocol review input
  • 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
  • MedDRA/WHODrug auto-encoding and manual coding
  • Blind/open randomization
  • Data import/export
  • CDISC data package
  • Risk management module
  • CTMS monitoring reports

Technology and System capabilities

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Electronic Data Capture (EDC) System

  • Compliant with all applicable regulatory standards
  • Support multi-language eCRFs
  • Full integration of external data (graphics, labs, CT assessments, X-rays, etc)
  • E-signatures
  • Clickable anatomical images
  • Online and PDF reports
  • Full-service EDC
  • Medical coding tool
  • Risk management

Interactive Web Response System (IWRS)

  • Supports open or double-blind randomization
  • Multiple patient groups support
  • Randomization based on blocklist or minimization algorithm
  • IMP accountability modules
  • Part of one EDC platform

Why Partner with the SanaClis Data Management Department?


  • As an active member of the CDISC organization, SanaClis is committed to enabling information system interoperability to improve medical research and related areas of healthcare. Our Clinical Data Management department supplies high-quality services to support the clinical development of drugs and medical products. We use our powerful CDISC Certified & regulatory compliant EDC software suite and services of professional biostatisticians.
  • Our team delivers high-quality data on time and budget, thus avoiding costly delays. We offer full-service setup and system operation to complete technology transfer and support the complete lifecycle of the clinical trial. Our expert statisticians work closely with the CDM team to meet the needs and objectives of each specific project and provide a high-quality customized service.

 

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See how our Data Management Team helped our sponsor's Phase III Oncology study

Working on an international, multicentre randomized double-blind clinical trial in oncology spanning over 3+ years, the SanaClis Clinical Data Management department facilitated the success of the study by end-to-end support.

Clinical Data Management department was an essential part of the study conduct. Thanks to choosing a risk assessment strategy based on site health status and key parameters, the study team was always prepared to deal with anything coming its way.

Meeting Sponsors' Needs, While Overcoming Industry Challenges & Changes

Whether it is data review, eCRF design, database management, MedDRA or WHO DDE coding, custom reporting, user support, data analysis, archiving, or relevant documentation preparation, the SanaClis’ Clinical Data Management department has you covered. We value your time and budget, which is why we offer flexible, customized, end-to-end solutions for Clinical Data Management in one place. Working closely together with relevant departments, on an internal and external level, such as regulatory and clinical operations department, enables SanaClis Data Management department to stay ahead of the curve, to predict, adapt and implement necessary processes to deliver upon the sponsors needs. We strive to exceed the clients’ expectations and provide only the very best data.

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Speak to an Expert

Reach out to our team of experts to discuss your Data Management needs

Reach out here

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