To better understand CDISC standards, the requirements surrounding CDISC, and how Nuventra can assist your team in complying with CDISC standards, we have created a two-part blog on what you need to know about CDISC. Below are 1-5 of the 10 Things to Know About CDISC:
1. What Does CDISC Stand for?
CDISC stands for the “Clinical Data Interchange Standards Consortium.” CDISC is a global not-for-profit organization that actively develops data standards for the pharmaceutical industry. There are three major standards that CDISC supports. They are known as SEND, SDTM, and ADaM.
To learn more about these data standards and the PK portion of CDISC data formatting, visit Part Two of our Blog
2. What Does CDISC Do?
CDISC creates standards that support the acquisition, exchange, submission, and archive of data for medical and biopharmaceutical product development. The consortium releases guidelines and requirements that influence the FDA and PMDA on standards for both clinical and non-clinical data. CDISC uses Controlled Terminology (CT) to unify data collected across submissions.
CDISC standards support “medical research of any type from protocol through analysis and reporting of results. They have been shown to decrease resources needed by 60% overall and 70-90% in the start-up stages when they are implemented at the beginning of the research process.”
3. Why Does CDISC Matter?
Proper implementation of CDISC standards can decrease timelines and costs during drug development leading to a marketing authorization. The standardization of clinical data improves the science of drug development.
4. PMDA Requirements – October 1, 2016
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) switched to CDISC standards on October 1, 2016 and now requires that all submissions filed on or after October 1, 2016 to use CDISC compliant formats.
5. FDA Requirements – December 17, 2016
FDA will require all submission data for studies with an initiation date on or after December 17th, 2016 to be CDISC compliant. This includes the submission of NDAs, ANDAs, BLAs, & INDs. Please note however, that the FDA wants to see Sponsors and stakeholders actively transitioning their data into CDISC formats before the required date of December 17, 2016.
Are You CDISC Ready?
As a CDISC Gold Member, our CDISC experts at Nuventra are actively involved in all forms of PK CDISC standards and implementation. Make your pharmacokinetic SEND, SDTM, and ADaM datasets work with your CRO to ensure proper implementation of PK CDISC.
How Can Nuventra Help?
Nuventra has been an industry leader with regards to PK CDSIC standards by serving on the ADaM Working Group and PK Cross Functional Team. As a CDISC Gold Member, our CDISC experts are actively involved in all forms of PK CDISC standards and implementation. Make your pharmacokinetic SDTM, ADaM, and SEND datasets work with your CRO to ensure proper implementation of PK CDISC.
- Generate PK datasets for legacy, planned, and current studies
- Work with your CRO on CDISC implementation
- Provide advice for FDA submissions
Contact a member of our expert PK CDISC team to learn more about CDISC and to see if your datasets are in compliance with the FDA’s soon-to-be required CDISC Standards.
Want to know more about CDISC and how it relates to PK Data? Read Part 2 of our Blog: 10 Things to Know About CDISC: PK Data & CDISC Standards