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CDISC | Ephicacy

CDISC

Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.

Ephicacy is a CDISC Gold member. Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater efficiency.

OUR CDISC SERVICES:

  • Conversion of Legacy raw data into SDTM datasets
  • Compliant Submisson Data Packages – SDTM annotated CRF, define.xml
  • Analysis ready ADaM domains, ADaM define.xml
  • Validation documents and OpenCDISC Report
  • Reviewer's Guide
  • SDTM/ADaM Compliant Integrated Databases

We follow a three pronged approach to deliver high quality CDISC services to our clients:

Process

  • Established procedures, work instructions and checklists
  • Defined workflow to generate SDTM and AdaM standard data packages
  • Validation and verification strategy to ensure integrity and accuracy of deliverables
  • Project management to ensure smooth project execution
People

  • Expert programmers with prior domain experience
  • Exposure of implementing CDISC standards in diverse therapeutic areas
  • Emphasis on continuous learning and training to remain abreast with latest standards
Tools

  • Use of latest technology framework like OpenCDISC Validator to ensure adherence to standards
  • In-house Macro library with pools of SAS macros and utilities to achieve efficiency in conversion process
  • Automated system to generate Define.XML