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. 

Doctor and Patient
Modern clinician inputting diagnosis into an online data base
In a Meeting
Bottling and packaging of sterile medical products
 

Our Services

Modern clinician inputting diagnosis into an online data base.jpg

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 

Hand turning knob to select phases of vaccine clinical trial. Focus on postmarketing surve
Insurance Healthcare  Doctor analyzing medical  report and medical  on hospital background

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

Get in Touch

Yehezkel Ha-navi 12, Bet Shemesh Israel

+972-58 56 33 776

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