“TOGETHER WE REACH THE GOAL"
Standardized data enterprise wide
Reduced points of data entry
Re-useable structure, programming
Self populating modules
End-to-end data transparency
Robust (over 600) resident validation checks
Results - all CDISC compliant
Set-up hours reduced
Safety TLFs standardized
SAS programming automated
Project Management hours reduced
Clinical Study Monitoring time reduced
Programming hours reduced
Statistical Analysis time reduced
CSR writing time reduced
EDATAKA has developed the Eka CDISC SuiteTM family of products: the next generation Data Management platform that essentially automates the Clinical Data Management process.
Utilizing metadata architecture and accepted CDISC standards (ODM, CDASH, SDTM, LAB, Report, ADaM), the platform fully integrates all Data Management processes in a single end-to-end modular platform unique to the pharmaceutical industry.
This standardization and architecture greatly enhances the quality of data, speeds access to the data, and dramatically reduces clinical trial time to completion, while significantly reducing the cost of the trial.
EDATAKA provides precisely targeted solutions to meet and exceed your firm's objectives in study design, conduct, and analysis. We achieve this through our experience, commitment, excellence in technology, and its applications.
EDATAKA provides full services in compliance with CDISC standards, with end-to-end transparency. Our five-stage complete CDISC standards compliant services include Protocol and SAP Analysis, eCRF Design and Validation, Database Setup and Data Collection, SDTM/ADaM Dataset Creation and Validation, Statistical Analysis Result Presentation (Tables, Listings, and Figures) and Validation, and Study Writing and Publishing. Plus, a comprehensive quality control process is employed to ensure high quality delivery.