Data Management and Statistics

Services

Data Management

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.

Software Development

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

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