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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 customised 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

Maximise your data it to its full potential

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.

cdisc gold member

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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.
 
OUR 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 

Recent Examples of Mapping Programs

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.

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 utilising 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 Standard Operating Procedures (SOPs)

Providing advise on the implementation of company-wide standards

Large Scale ISS/ISE Development

Working on the development and creation of integrated summaries of safety & efficacy

Providing Easy Access to Data for Customers

Through the utilisation of internal iQ document storage, data visualisation, data analysis, and data storage portal

Development of Efficient Macros

To streamline the mapping process and TFL production 

Resources to help you format your data to regulatory standards

CDISC Define.xml Guide

CDISC Define.xml Guide

In this whitepaper, we will provide you with key points on how to prevent your CDISC Define.xml code from common mistakes using assumptions in the stylesheet; and simple adjustments and more complex examples.
Learn more
CDISC CDASH Guide

CDISC CDASH Guide

SDTM standards do not always lead themselves well to data capture, this guide looks at using CDASH standards to provide a common ground to facilitate the capture of data when linking processes across clinical data management and clinical programming.
Learn more
Integrated Summaries (ISS/ISE)

Integrated Summaries (ISS/ISE)

Quanticate outlines the issues that can arise in the planning of an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
Learn more

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We are here to help ensure your data is formatted to regulatory standards.

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