Clinical Data Management

Our Data Management experts support you in the management of your clinical data: from the CRF creation all the way through to validation and database freeze.

 

Our offer

 eCRF : Case Report Form

  • CRF Conception
  • CRF Review
  • CRF Annotation

 

Clinical Database Design: CRF Design

  • Specific Module Creation
  • Input Screen Creation
  • Input Screen Validation

 

Coherence Controls Program

  • DVP Data Validation Plan
  • Programming EC coherence controls
  • (Edit Check) in PL/SQL
  • Data Consolidation
  • Listing of DRFs (Data Resolution Forms)
  • Validation: Single, double and intermediate double input
  • Data distribution

 

Amendment Management

 

Study Completion: Database Freeze

  • Global Coherence Verification
  • Post-market Surveillance
  • Reconciliation
  • Coding Review by the developer
  • Tracking of protocol deviations throughout the study process
  • Data presentation at the Blind Review

 

Database Administration

  • Functional Administration
  • Data Exploitation (Crystal Report Requests)
  • Implementation of various reports (Monitoring, Close out Visit)
  • Clinical Study Planning