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Quanticate - Clinical Research Organization

EXPERTISE

CDISC Services & Mapping

Ensure your data is formatted to regulatory required data standards.

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What is CDISC?

Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that defines and manages industry level platform-independent data standards that are widely used during the analysis, reporting and the regulatory submission of clinical data.

For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets.

Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files. At Quanticate we offer a range of CDISC Services and are experienced in mapping to CDISC Standards.

CDISC Services

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 

CDISC Mapping Expertise

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
     

Quanticate have been involved in a number of successful mapping projects for submission, reports, or publication purposes. Our CDISC working group has experts that are actively involved in CDISC User Groups and that ensure all programmers have been trained in CDISC. 

RECENT EXAMPLES OF MAPPING PROGRAMS INCLUDE:

  • Conversion of over 80 studies from analysis data to CDISC ADaM standards 
  • Time-critical mapping of legacy studies to SDTM 
  • Working with a large pharmaceutical company on submission strategy utilizing internal standards, including QC and pooling strategies 
  • Advising a mid-size pharmaceutical company on approaches for ADaM conversion of legacy and currently running studies 
  • Advising on the implementation of company-wide standards 
  • Large scale ISS/ISE development 
  • Utilization of internal iQ document storage, data visualization, data analysis, and data storage portal to provide easy access to data for customers 
  • Development of efficient macros to streamline the mapping process and TFL production 

Our large, global scale enables us to provide expertise and support to meet your needs in an efficient and high-quality way. Your data is the most important outcome of your clinical trial and is the result of a huge amount of investment - make sure you maximize it to its full potential.

cdisc gold member

Ensure your data is formatted to regulatory required data standards

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Resources to help you format your data to regulatory standards

WHITEPAPER

Prevent common mistakes when using Programming Define.xml code
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WHITEPAPER

Learn how to Link Clinical Data Management to Clinical Programming and Vice-Versa
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BLOG

Discover more about the CDISC SDTM Standards the advantages of its application
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CASE STUDY

How to integrate CDISC ADaM standards for ISS/ISE Submissions
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