ISSUE NO. 26 — CDISC Data Standards

The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.

In Issue 26 of The Altascientist: 
•    Introduction to standardization and its benefits
•    Client considerations for nonclinical and clinical data standardization
•    Case Study — Realized Efficiency
•    Case Studies — Legacy Data Conversion
•    The future of CDISC and data strategy

Why is Data Standardization in Drug Development Important?

There is tremendous value in standardizing and sharing data: organizations across the globe that are using CDISC standards produce faster, more efficient research, and pave the way for more breakthroughs that amplify the power of data, in both the short- and long-term.

“Adherence to data standards is integral to successful and efficient drug development for our clients,” says Nicole Maciolek, Vice President, Research Services, Medical Writing and Scientific Affairs, at Altasciences. “We are experts in applying CDISC standards, from preclinical SEND to clinical CDASH, SDTM, and ADaM. We are proud to be Gold members of the CDISC consortium, and to bring the advantages of standardization to all the data we deliver.”

Data that is presented in a well-organized, templated fashion is easier for regulatory reviewers to understand and interpret, which limits requests to sponsors for clarification or resubmission. The CDISC standards cover all types of data, from nonclinical to Phase III, across therapeutic areas, and are required for all studies supporting marketing authorization.

Sponsors benefit from data that is of high quality, easy to interpret, and leads to sound, swift go/no-go decisions. Regulatory bodies benefit from a smooth, consistent process that allows them to analyze all the data submitted in the same way, without concerns about the organization or interpretation of data that may be structured differently.

How Altasciences Ensures Compliance With CDSIC Data Standards

We ensure that our team is always up to date with the latest trends and guidelines in regard to CDISC standards. We utilize a suite of proprietary validation checks, as well as Pinnacle 21 Enterprise version technology, to load, review, and validate SDTM and ADaM data and Define.xml files. Our CDISC experts are available on a per-project or full-time equivalent (FTE) basis, according to your needs. Our team has converted data from clinical trials, in diverse therapeutic areas, to CDISC-compliant SDTM and ADaM datasets, as well as designed CDASH-compliant forms and databases for streamlined data management and reporting.

Click here to learn more about our clinical data management capabilities.  

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