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How To Handle Skipped Questions in SDTM QS Domains

Posted by Kevin Burges on Nov 13, 2017 4:00:21 PM

Standardized questionnaires often contain questions that should only be answered depending on the response to a previous question.  Until now, such data has been submitted inconsistently to FDA, as CDISC SDTM does not provide any guidance on how to indicate that the questions have been "logically skipped". Thankfully FDA have just updated their Study Data Technical Conformance Guide to standardize how information about these logically skipped questions should be submitted. It's fairly simple...

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Topics: FDA, SDTM, ADaM

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

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

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

Saving Lives, Time and Money At The Same Time

Posted by Kevin Burges on May 17, 2016 1:52:23 PM

I recently took to LinkedIn Pulse to share my thoughts on the challenges organizations face in getting new drugs to market. In this blog, I also explore the initiatives taking place to overcome these challenges and ultimately optimize the drug development process.

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Topics: FDA

The Monday Morning Briefing: FDA and Google discuss mining side effect search data

Posted by Fiona Hartley on Jul 20, 2015 11:36:16 AM

Morning! I’m sure you know the drill by now, but in case you don’t: here are the biggest pharma news stories of the week - digested and distilled for your perusal. Enjoy!

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Topics: FDA, News, Pharma

The Monday Morning Briefing: merger madness and FDA updates

Posted by Fiona Hartley on Apr 27, 2015 1:06:53 PM

Morning! We're experiencing merger déjà vu today: the latest Teva, Mylan and Perrigo developments should feel awfully familiar to anyone who's been following the pharma merger merry-go-round these past few months. Read on, be enlightened, and - most importantly - tell your colleagues how you came to know everything about this week's industry news.

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Topics: FDA, News, Pharma

15 Changes in Clinical Trials Since 2000: Part 2

Posted by Fiona Hartley on Mar 16, 2015 4:28:38 PM

We’re celebrating the 15th Anniversary of Formedix this year. It got us thinking about how the clinical trials world has changed since we've been around: sometimes it feels like little has changed in 15 years, but often it feels like the pace of change is unsustainable. This is the second in our three-part series - part one is here, and part three is here. Read on for part two of our top 15 things that have changed in clinical trials since 2000.

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Topics: End-to-End Clinical Trials, FDA, #Formedix15, Pharma, Submissions