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Cost-benefit Analysis for the Implementation of CDISC Standards During Clinical Trial Setup – Calculating the Break-even Point - Part 2

Posted by Jasmine Kestemont on May 24, 2018 2:21:00 PM

In the second article of this two-part series, Jasmine Kestemont from Innovion delves deeper into the cost-benefit analysis, focusing on the upfront investment required to implement CDISC standards at study setup and the break-even points for three different levels of standardization.

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Topics: CDISC, Standards, clinical trials

Cost-benefit Analysis for the Implementation of CDISC Standards During Clinical Trial Setup – Part 1

Posted by Jasmine Kestemont on May 18, 2018 4:26:26 PM

In a two-part series, guest blogger Jasmine Kestemont, Managing Partner at Innovion, shares her findings from a cost-benefit analysis for CDISC data standards implementation during clinical trial setup. In this article, Kestemont reviews study setup activities from protocol to Define.xml creation, highlighting that any level of standardization has a direct and immediate impact on the effort required for trial setup. 

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Topics: CDISC, Standards, clinical trials

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

The Twelve Days of Formedix

Posted by Fiona Hartley on Dec 14, 2016 3:11:33 PM

The festive period is in full swing, and in the Formedix office, we’re no exception. While we sample festive chocolates, raise a glass over Christmas lunch, or add the star to the top of the office tree, we look back over the year and give a nod to all the great things we’re excited to offer, here at Formedix.

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Topics: CDISC, Define-XML, EDC, SDTM, Services, Software, Standards

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

CDISC Define-XML 1.0 Comes to the End of its Life

Posted by Fiona Hartley on Jul 28, 2016 2:31:14 PM

REGULATORY DEADLINE UPDATE: The FDA Data Standards Catalog has recently been updated to state that Define-XML v1.0 cannot be used in studies starting after March 15, 2018 . The Catalog previously stated March 2017, however the update now aligns with the date communicated on the Federal Register Notice.

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Topics: CDISC, Define-XML, FDA, Services, Software, Standards

Eh... What's SUPPQUAL? An Introduction to Supplemental Qualifiers

Posted by Fiona Hartley on Oct 8, 2015 4:12:31 PM

In last week’s blog, we looked at the SDTM mapping process and ended on the cliffhanger of the supplemental qualifier. These tricky little tidbits are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. Let’s look at them in a little more detail.

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Topics: CDISC, CRFs, SDTM, Standards, Supplemental Qualifiers

3 Things You Should Know About the Analysis Data Model (ADaM)

Posted by Fiona Hartley on Sep 4, 2015 3:02:02 PM

One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate figures, listings and tables more easily, and ensures traceability, which means that reviewers are able to review and approve a submission more quickly.

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Topics: CDISC, SDTM, Standards, ADaM

Mark Wheeldon Discusses CDISC Standards From the Start: Part 2

Posted by Fiona Hartley on Jan 22, 2015 5:43:04 PM

This is the second of a two-part blog discussing CDISC standards from the start with Formedix CEO Mark Wheeldon. If you haven't read the first part yet, you'll find it here. Below are the slides from Mark's CDISC International Interchange 2014 presentation, CDISC: Standards from the Start, which accompany the discussion.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, End-to-End Clinical Trials, Standards

5 Things You Didn't Know Define-XML Could Do

Posted by Fiona Hartley on Dec 11, 2014 2:51:49 PM

Just like Dr. Pepper, Define-XML is so misunderstood. There’s a common misconception among CDISC users that it is simply a way to document what datasets look like. Sure, Define-XML can be used to document the names and labels of dataset variables, and it can document what terminology is used. It does that brilliantly. But thinking of Define-XML solely as a dataset descriptor does this standard a massive injustice.

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Topics: CDISC, Define.pdf, Define-XML, Standards