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Clinical Research Data Management: data processed accurately

ATLANSTAT masters the data management process in accordance with international recommendations (EMA, ICH, FDA).
The data are handled according to strict safety and traceability rules precisely applied by a skilled, stable and experienced team.

Tools

Data Management is supported by ENNOV CLINICAL.
This tool meets FDA requirements (21 CFR Part 11) and its implementation within the ATLANSTAT computer system was fully validated.

This tool allows both paper and e-CRF (electronic Case Report Form) management. Study data can be completely managed from the development of the CRF database to the locked and validated database for accurate statistical analysis.

This CTMS (Clinical Trial Management System) creates a complete audit trail for optimal traceability of all actions performed on the database.

Database set-up

Data management
  • Defining user profiles in a dedicated server using an Oracle database
  • Constructing the database (CDISC possible)
  • Setting the input scenarios
  • Setting import / export data
  • Integrating standard or specific modules 
  • Managing codelists
  • Designing case report forms (CRF)

Data Validation

  • Data validation plan writing
  • Edit check development and defining the applications conditions
  • Data Clarification Form (DCFs) creation, management and data entry
  • Implementating listings for clinical review
  • Managing manual DCF
  • Managing of investigators comments and data entry of DCFs
  • Programming, editing "Patient Profiles" and individual data
  • Possible online data management follow-up
  • Coordinating and managing of external data

Medical coding data

  • Signs and symptoms, disease history, adverse events coding with MedDRA (VEDDRA)
  • Treatment coding (WHO DDE)
  • Listing editing with auto-coding events and decodes

Quality control and managing study end

  • Interim analyzes management (Cut-off, date)
  • Reconciliation of pharmacovigilance reports
  • Entry Audit, quality control (Plan and Audit Report)
  • Full support of the final data review
  • Database lock
  • Database transmission in different format (.sas, .csv, .txt, .xml, ...) if necessary in SDTM

GIDB (Global Integrated DataBase)

Implementing Global Database to produce results from several "pooled" studies