ClinXL

We are a boutique company that offers high-level data services for clinical trials. Our Data Management services include: - 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 - Medical Coding using WHODrug & MedDRA Dictionaries - Safety & Lab Data Reconciliation - Data Cleaning and Query Management - Data Export/Transfer - Real-time Data Viewing and Reporting - CDASH Compliant Deliverables - CDISC SDTM Data Conversion service - Data lock and archive Our Statistical services include: - Sample size calculations - Statistical section in protocol - Statistical analysis plans - Collaboration with the data manager to ensure quality data for the study endpoints - High level data review - Statistical analysis with up to date statistical methods - Production of tables and figures that are easily comprehended - Clear statistical reports - Document the statistical methods used and any relevant statistical references - Paper review - Statistical report for submission to regulatory authorities.