EDATAKA A contract research Organization

YOUR SUCCESS

Metadata driven

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

OUR TEAM

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.

OUR SOLUTIONS

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.

CDISC SuiteTM

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.