Clinical Informatics

  • 21 CFR part 11 and GDPR (General Data Protection Regulation) compliant, in-house developed eCRF platform solutions supporting all clinical study teams and aspects (Source Data Verification, Drug management, electronic Serious Adverse Event reporting, electronic Product Quality Complaint reporting, electronic Pregnancy reporting, notifications etc.)
  • Complete customization of the platform throughout the project to suit client needs
  • Design and publication of Clinical Study Reports (eg. Patient Disposition, Data Entry, Medical Review Listings, SDV Repots etc.) and Dashboards
  • KPI extraction, metrics definition, data presentation in graphs, tables and charts, drug forecasting and macroscopic ad hoc analyses