Capabilities

Data Management

Comprehensive Support for Quality Data Collection, Curation, and Analysis

Case Report Forms

  • Design of study data elements based on protocol
  • Development of hardcopy and electronic worksheets and data collection forms

Cloud EDC Database

  • Clinical study database customization and deployment
  • eCRF creation and form rules
  • Internal consistency, error, and edit checks
  • User acceptance testing (UAT)
  • Validation testing
  • User training and support

Data Quality Control

  • Ensure study data is submitted, source verified, and available in real time
  • Data query and discrepancy resolution
  • Summary data, metrics, and visualizations reporting
  • Final data un blinding and reporting

Biostatisics

  • Sample size analysis
  • Statistical analysis plan (SAP)
  • Analytical study design
  • Clinical validation study design
  • Study interim analysis
  • Sample size re-estimation
  • Study final data analysis

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