certania_services_Data_management_eCRF

Data management, eCRF

Optimal solutions for eCRF and electronic data capture.

Efficient data management for clinical trials.

Our flexible and secure eCRF systems provide customized solutions for your clinical trials. Whether digital or analog, we design the ideal data capture concept in accordance with internationally recognized standards like FDA 21 CFR Part 11 and EMA Annex 11. With intuitive user interfaces and comprehensive features such as edit checks and query management, we ensure the highest levels of data quality and compliance.

Overview of our services

  • CRF Design
    - Creation and customization of paper-based and electronic CRFs
    - CDASH-based data concepts

  • Electronic Data Capture (eCRF)
    - Fully browser-based
    - Compliant with FDA 21 CFR Part 11 and EMA Annex 11, GAMP5 principles

  • eDiary / ePRO
    - Integrated within the eCRF system
    - Allows mobile data entry by subjects

  • Edit Checks
    - Automated and manual plausibility checks to ensure data quality

  • Query Management
    - Efficient communication and resolution of data discrepancies

  • Coding
    - MedDRA and WHO-ATC coding performed by qualified professionals

  • Databases and Database Closure
    - Ensuring data integrity and finalization of the database

  • CDISC-Compliant Datasets
    - Creation of SDTM and ADaM datasets according to international standards

Our Experts:

SocraMetrics
Specialists in clinical data management and biometrics. Learn more

The industries:

  • Life Science
  • Pharma
  • Scientific Community
  • Food
  • Consumer Goods
  • Chemical
  • Manufacturing
  • Public Communities