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Using NCI Controlled Terminology for Standardizing Data

Posted by Kevin Burges on Feb 5, 2018 4:30:00 PM

Use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and ADaM standardize the structures to use when collecting and submitting data, but what about the data values themselves?

This post gives an overview of CDISC's standardized controlled terminology and how it should be used to collect and submit data in a way that speeds trials and enables cross study analysis.

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Topics: CDISC, Controlled Terminology, Regulatory, SDTM, SEND, Submissions, ADaM

Using SDTM, ADaM and SEND for Regulatory Submissions

Posted by Kevin Burges on Jan 29, 2018 4:30:00 PM

It's a safe bet that most people's first introduction to CDISC is through the SDTM. This is a content standard that ensures clinical data is submitted in a consistent manner, helping reduce review time and facilitating cross study analysis. Another content standard, ADaM, aims to perform a similar function for analysis datasets. Likewise SEND defines standardized domains for non-clinical data. 

Adoption of these standards is driven by regulators such as FDA and PMDA, who mandate that data must be submitted in these formats.

This post gives a very brief overview of each model, how they fit in with the wider clinical trial process, and how you can get maximum benefit from them.

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Topics: CDISC, Regulatory, SDTM, SEND, Submissions, ADaM, Analysis Results Metadata

Standardized data - The industry is struggling

Posted by Kevin Burges on Oct 2, 2017 1:30:36 PM

With FDA now regulating for all new studies to use CDISC standards when submitting data, it's vital that our processes are up to date with the latest standards and fit for purpose.

An FDA presentation at the recent PhUSE Computational Science Symposium tried to shed some light on how we're doing as an industry. It analysed all eCTD submissions from January-February 2017 that used standardized data.

You might be surprised how the submissions fared...
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Topics: CDISC, Datasets, Define-XML, FDA, Regulatory, SDTM, SEND, Standards, Submissions, Training

When Should I Use CDISC SDTM v1.5?

Posted by Ed Chappell on Sep 27, 2016 12:36:13 PM

Earlier this month, I participated on the Q&A panel for our CDISC SDTM-IG webinar. During the webinar we received an interesting and very timely question around the use of CDISC SDTM v1.5. I was asked “CDISC have released SDTM 1.5, should we use this instead of SDTM 1.4?”  So here is my quick guide on the appropriate use of the standard…

 

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Topics: CDISC, FDA, Regulatory, SDTM, SEND, Standards, Submissions

In the News: Standardized Submissions — Are You Prepared?

Posted by Fiona Hartley on Jun 30, 2016 12:03:10 PM

Formedix recently attended the DIA 52nd Annual Meeting in Philadelphia, PA, featuring in The Clinical Oncologist Daily show magazine for the initiatives we have put in place to help organizations prepare for the impending FDA regulatory deadline. Read the full interview below with Solutions Consultant Lesley Gordon below.

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Topics: CDISC, Conferences & Events, FDA, Regulatory, Training