CDISC. Data Standardization

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, leading to the need to convert existing data into CDISC standards.

Our CDISC services:

• Document creation includes SDTM annotated CRF, SDTM metadata
• Generation of .xpt file from SDTM/ADaM definitions
• Study mapping with CDISC standards for ISS/ISE reporting and regulatory submissions
• Creation of documentation for integrated databases
• Support in standardization of data conversions
• CDISC/CDASH compliant SAS Programming
• Generation of Define.xml Utilities and Define.pdf Documents
• Metadata and Data Repositories
• Conversion of Legacy raw data into SDTM datasets
• Converting CDISC ODM XML to SAS datasets
• Mapping to SDTM/ADaM standards
• Generating SDTM data, CRT-DDS (define.xml), ADaM conversion specifications and comprehensive study data reviewer’s guide (SDRG)
• Analysis ready ADaM domains, ADaM define.xml
• ADaM-related document creation: analysis and variable level, parameter level and dataset level documentation
• Gap Analysis of study data
• TLF (Table Listings Figures): Creation of Analysis Data Model (ADaM), Safety efficacy tables, SDTM mapping using CDISC standards, listings and graphs as defined in the SAP and Mock shells
• SDTM/ADaM Compliant Integrated Databases
• Creating ADaM domains to support TFL output
• Validation of data and definition of files
• CDISC compliant SDTM and ADaM specifications and their implementation in SAS programs
• Maintaining data traceability from CRF to CSR
• Developing annotated CRF and SDTM data conversion specifications