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i-CDMS®: The #1 EDC & eCRF for clinical trials



i-CDMS is an innovative cloud based system offering a complete set of features for streamlining trial monitoring and data entry with e-CRF, automated edit checks and queries resolution, patient and site reporting, real time notifications and reminders and others that are accessible from all trial participants according to their roles.

i-CDMS has been built with the latest technology tools and state of art user interface consisting a fully qualified EDC for supporting all types of trials. from the investigators and the wide advantages it offers in monitoring and control of clinical trials.

Today i-CDMS is the #1 choice of many sponsors due to its easiness of use, its quick adoption from the investigators and the wide advantages it offers in monitoring and control of clinical trials. i-CDMS has passed full system validation in accordance with international regulations and complies to 21 CRF part 11 and HIPAA requirements. i-CDMS is accessible via the internet without any other special requirement or installation needed at the site.

  • Electronic Data Capture (eCRF)
    Autosave functionality. i-CDMS never looses data (no save button). Easy & guided data entry. Double Data Entry for paper based studies.
  • Discrepancies tracking
    Data Clarification Forms (DCFs) are generated electronically and can be resolved by the investigator on i-CDMS. All queries are tracked and identified with Query Lifecycle Statistics (QLS) metadata. Data managers, monitors, and CRAs know in real time the exact status of queries and can follow the audit trail of the changes.
  • Audit Trail
    Detailed inchangable audit trail is recorded and accessible via filters and search functionality for all study and iCDMS data
  • Randomization & Blinding
    Random patient selection for drug/placebo intake. Blinding of drugs for all study members with emergency breaking
  • Safety
    AEs and SAEs are submitted electronically to PhV or authorities with confirmation functionallity. All safety reports for authorities can be generated automatically (DSUR, PSUR etc)
  • Risk Based Monitoring
    Design the study with Risk based monitoring, cut monitoring costs and increase efficiency through interactive Risk monitoring charts.
  • CDISC standards (SDTM and ODM)
    We follow international standards for database design, data export and import
  • Patient Recorded Outcomes
    Available to any format of for electronic submission
  • Electronic signatures
    Investigators,doctors etc can electronically sign documents eligible for authorities submission
  • Accounting Integration
    Manage costs, payments and schedules
  • SDV
    Perform and record Sourcer Data Verification activities and monitor them through out the study. SDV in invalidated automatically on the event of clinical data change
  • HIPPA compliance
    Special preparation has been taken on Azure Cloud infrastructure for compliance with HIPPA and 21 CRF part 11