Electronic data capture – EDC

Electronic Data Capture: Improving the Speed and Quality of Your Clinical Trials

Electronic data capture improves the efficiency and accuracy of data collection, gives faster access to clinical data, speeds up the decision-making process, and reduces the overall cost of clinical trials. Electronic data capture (EDC) technology is encouraged by the FDA because it gives significant benefits to sponsors, investigators, and patients, including more accurate clinical data that can be shared more easily and monitored, increased compliance with regulatory requirements, and lower overall costs of the study.

IDDI provides real-time electronic data capture (EDC) to ensure data quality and compliance across all sites. ID-base™ (powered by XClinical) is a robust EDC system that is validated and CDISC-compliant (according to all regulatory requirements). This user friendly EDC system FULLY INTEGRATED with our interactive web-response system (IWRS) includes a drug supply management feature and makes it a uniquely competitive option.

ID-base™: User-Friendly Electronic Data Capture Integrated with IWRS SystemElectronic data capture

IDDI uses ID-base™ (powered by XClinical), an EDC system for all clinical trials phases ‘designed by investigators for investigators’.

Since 2008 IDDI has implemented:

92
EDC Studies

KEY BENEFITS OF OUR ELECTRONIC DATA CAPTURE SYSTEM ID-base:

  • Data management system with electronic data capture, ID-base™ (powered by XClinical)
  • Integrated with IWRS  (ID-net™) 
  • First to have received the Operational Data Model (ODM) certification from CDISC
  • No software installation required or firewall settings at sites
  • Data acquisition and audit trail in compliance with 21 CFR Part 11
  • Online reporting
  • Flexible system (customized per-study data flow, signature flow, user roles etc.)
  • User-friendly and easy (dynamic display of fields/forms/visits coupled with a simple query process)
  • Virtually no downtime
  • Browser-independent
  • Supports multi-language and regional date/time formats
  • Allows documentation of source data verification (SDV) by monitors
  • Patient-reported outcomes (ePRO) via web diary
  • 24/7 availability and worldwide coverage (system and helpdesk)
  • Integrates binary data (graphics, images, X-rays, ECGs, etc)
  • Easy and accelerated study set-up
  • Flexible (easy protocol amendment management)
  • Limited training needed

ID-base™ (powered by XClinical) has been used since 2002 in:

560
trials
220000
subjects
60
countries on all continents