Data Management and Statistics

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  • From CRFs design to legacy database integration
  • Development and execution of study specific Data Management Plans
  • Development and execution of study specific Data Validation Plans
  • Coding with accuracy and consistency, supporting all dictionaries
  • Metrics and reports production to support clinical project management
  • Queries resolution and management
  • Merging and consolidation of safety and clinical databases
  • Clinical Data Interchange Standards Consortium (CDISC): development of Study Data Tabulation Model and Analysis Data Model datasets (SDTM/ ADaM respectively). Data preparation for regulatory submissions.
  • 21 CFR part 11 and GDPR (General Data Protection Regulation) compliant, in-house developed eCRF platform solutions supporting all clinical study teams and aspects (Source Data Verification, Drug management, electronic Serious Adverse Event reporting, electronic Product Quality Complaint reporting, electronic Pregnancy reporting, notifications etc.)
  • Complete customization of the platform throughout the project to suit client needs.; changes implementation the soonest possible to timely address client and project requirements
  • Production of comprehensive audit trail logs of all user activities
  • In house validated library of SAS© programs
  • Statistical design of all aspects of clinical trials / endpoint selection and validation
  • Development of Statistical Analysis Plans (SAPs)
  • Calculations of sample size and development of Interim Analysis Plans
  • Development of tabulations, listings, and graphical presentations
  • Development of statistical reports

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