Our Services

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Clinical Data Management

EDC released in less than 4 weeks

  • Consultancy (strategic program planning, protocol review ...)

  • EDC Set-up and Management with the best state-of-the-art in the domain

  • Data Management Plan (DMP) Development 

  • Project Management 

  • CRF/eCRF Design, Development and Maintenance 

  • CRF Annotation & Review 

  • Database Build & Design 

  • Data Validation Specifications 

  • Edit Checks Programming & Testing 

  • Data Cleaning and Query Management 

  • Medical Coding using WHODrug & MedDRA Dictionaries 

  • Safety & Lab Data Reconciliation 

  • Data Export/Transfer 

  • Real-time Data Viewing and Reporting 

  • CDASH Compliant Deliverables 

  • CDISC SDTM Data Conversion service

  • Data lock

End-to-End Development, Infrastructure & Support

International support services for all trial types & phases

  • Selection of the most suitable Electronic Data Capture system according to your trial specifications.and budget.

  • Wide Experience in both device and drug studies

  • Advanced EDC features available: e-Consent, DICOM viewer, ePRO....

  • SSOT : Single Source of truth 

  • Hotline Services 6/7

  • Helpdesk provided in 4 languages : English, Hebrew, French and Spanish

  • Custom Training sessions for each role in the clinical study

  • Responsive and Trustworthy Support 

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Statistical Activities

Study Design

  • Sample size calculations

  • Statistical section in protocol

  • Writing of statistical analysis plans

  • Coordinate with data management to ensure quality data for analysis of study endpoints

Statistical Analysis

  • High level data review

  • Perform detailed statistical analysis with up to date statistical methods

  • Produce tables and figures that are easily comprehended

  • Explain the results clearly and write a report with a clear description of the results

  • Document the statistical methods used and any relevant statistical references

  • Review papers or other communication that is drafted about the results

  • Prepare statistical report for submission to regulatory authorities.