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CDISC CDASH SDTM Consultation

CDISC CDASH SDTM Consultation

RPM Alliance is a CDISC Member. We have constant access to new data standards regarding CDISC standards. We have seasoned professionals experienced in AdaM, SDTM and CDISC related services. We have helped many companies incorporate CDISC, SDTM and ADaM standards into their organizations and studies to generate the essential uniformity in formats. We believe in optimising and customising according to our client demands supporting operational standardization. We have proficient statistical programming team known to cut down time and costs, ensuring consistency towards our clients.

RPM Alliance has expert programmers with prior domain experience offering wide range of AdaM and SDTM services like converting standard DBs to SDTMs, validating procedures from SDTM data to ADaM data and CRT-DDS (define.xml) generation, creating and developing workflows and reviewers guide, consultation on operational and validation procedures, validation and verification strategy to ensure data integrity reliability and accuracy, advise on the execution of company-wide standards, guidance on generating ADaM data to statistical analysis results based in compliance with procedures, work instructions and checklists. We also offer audit service with regards to CDISC standard conformity requirements analysis. Alongside, we also provide support service to deploy clinical data collection, processing and analysis in compliance with best industry practices.

CDISC CDASH SDTM ADAM 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 define files
  • CDISC compliant SDTM and ADaM specifications and their implementation in SAS programs
  • Maintain data traceability from CRF to CSR
  • Developing annotated CRF and SDTM data conversion specifications
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