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Randomisation


Randomisation prevents selection bias and insures against accidental bias.
eClinica does more and brings innovation in your clinical trials with an IVRS/IWRS, meaning facilitated use and more flexibility by guaranteeing data integrity and safety.
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Main Features


  • User friendly e-platform
  • Multi-languages (280 languages)- the interface language automatically adapts according to the user’s browser language preferences
  • Single script for IVRS and IWRS
  • Interaction between eCRF and eRS
  • Help-desk 24/7
  • Fast study build
  • Easily customized to the specific need for each study
  • Online reports
  • Accessible on Iphone, Google Android...
  • Investigators can use it easily and quickly from everywhere

IVRS/IWRS services


  • Randomization (different method: permuted blocks, minimisation, ...)
  • Treatment reallocation (dose adjustments, ...)
  • Emergency re-supply
  • Emergency unblinding
  • Withdrawal
  • Centre management
  • Shipment receipt
  • Treatment deactivation
  • Web reporting

Drug supply management


  • Treatment ordering
  • Expiration dates management
  • Inventory management

Security Features


  • HTTPS secured
  • Definition of role based user access rights per project
  • Fully automated CFR-21 part 11 audit trail
  • Full support to to enable compliance with GCP, 21
  • CFR Part 11 and other regulatory guidances
  • GCP (Good Clinical Practices) compliant
  • Hosted in a secure data center with a SLA

Regulations


Our products are designed and developed in accordance to the latest regulations and guidances. Our Quality Assurance department ensures that they are supporting your GCP compliance (FDA 21 CFR Part 312, Part 812 and Part 11, Eudralex Vol 10, ICH E 6 (1), ICH Q9…).

Quality Assurance


Verification & Validation model is applied to our solutions according to standard guidance (GAMP5, FDA Computerised Systems Used in Clinical Investigations, IEEE 1012-2004).

Data portability


eClinica promotes data interchange standards implementation according to HL7, CDISC ODM, CDISC SDTM, CDISC CDASH, CDISC LAB and CDISC BRIDG.