Data Management

Data management plays a vital role in the clinical research process as it ensures the completeness, accuracy and consistency of the data as well as the delivery of auditable quality clinical study results.

In CORONIS we use the most advanced and comprehensive clinical data management software available, as ORACLE, SPSS and MS SQL, while our “real-time” interfaces allow you to have "immediate" access to study's data in a way that improves data quality and minimizes timeline risks.

Our highly qualified Data Management Team works closely with the client in order to define project's needs and customize the available software in order to ensure a successful and timely database development, management, lock and transfer that can fulfil project's requirements and achieve sponsors' particular needs and preferences.

Our Data Management Services include:

  • Database Design and Development 
  • EDC platform design, Programming and Validation (compliance with FDA 21 CFR requirements)
  • Full electronic Audit Trail
  • Data Management Plan
  • Programmed Edit Checks
  • Data Entry (single & dual) & Verification
  • Data Validation and Discrepancy Management
  • Query Management
  • Annotated CRF/eCRF
  • Data Clarification Form Tracking System
  • AEs and SAEs Reconciliation
  • Medical Coding using Standard Dictionaries (e.g. ICD-10)
  • Quality Control
  • Data Outliers Identification and metrics
  • Database Lock Procedures


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