CDISC Compliance and Mapping

Quanticate has extensive experience in helping its customers become CDISC compliant. We have worked on large and small CDISC specific projects, some involving only consultancy and others involving mapping of multiple studies to CDISC standards. OUR SERVICES INCLUDE: - Creation of customized CDISC solutions - Building new CDISC CDASH/SDTM compliant databases - Creation of CDISC SDTM domains from various customer defined data standards - Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission - Compatibility with any version of the SDTM/ADaM and define.xml standards/Implementation Guide - Converting CDISC ODM XML to SAS® datasets and vice versa - Creation of the define.xml package, including reviewers guides, annotated CRFs and - SAS V5 XPT files for regulatory submission to the FDA - Creation of ADaM domains to support TFL output and maintain data traceability from -- CRF to CSR - Statistical programming using ADaM derived datasets as inputs to the SAS® report code As experts in the mapping of clinical and research data, Quanticate can ensure a successful mapping strategy is put into place and then delivered. We are able to advise and provide services in relation to data integration and data conversion of data to SDTM and ADaM formats. SERVICES INCLUDE: - Advice on which data structures to convert to and when/why - Development of company standards to ensure data consistency across phases/therapeutic areas which enables pooling and ensures data is submission-ready - Mapping of current and legacy study data to SDTM and/or ADaM - Recreation of TFLs and appropriate QC strategies - Creation of ISE and/or ISS - Creation of submission packages, including define.xml