.png){kind=small}
ClinXL
Your clinical trial, Our excellence
Clinical Data Management
Data are the building blocks providing both insights and results from any clinical trial or study. Using effective data governance as a starting point, combined with both the right data infrastructure/ecosystem and a strong methodology is simply a way to success, while poor data management will lead to error-prone systems.
 |  |  |  |
|---|
Our Services
Clinical Data Management
Accuracy, Reliability and Efficiency
-
Consultancy (strategic program planning, protocol review ...)
-
Data Management Plan (DMP) Development
-
Project Management
-
Support for CRF/eCRF Design
-
CRF Annotation & Review
-
EDC Set-up and Management with the best state-of-the-art in the domain
-
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 and archive
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
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.
Opening Hours
Come Visit
Sun - Thu: 8am - 5pm
Fri: Helpdesk only
Sat: Closed
