The Formedix Clinic

Drop in and catch up on the latest news and standards knowledge. No appointment necessary.

How To Handle Skipped Questions in SDTM QS Domains

13 November 2017
by Kevin Burges About The Author

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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Standardized data - The industry is struggling

2 October 2017
by Kevin Burges About The Author

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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When Should I Use CDISC SDTM v1.5?

27 September 2016
by Ed Chappell About The Author

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

28 July 2016
by Fiona Hartley About The Author

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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In the News: Standardized Submissions — Are You Prepared?

30 June 2016
by Fiona Hartley About The Author

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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Saving Lives, Time and Money At The Same Time

17 May 2016
by Kevin Burges About The Author

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

20 July 2015
by Fiona Hartley About The Author

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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The Monday Morning Briefing: merger madness and FDA updates

27 April 2015
by Fiona Hartley About The Author

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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15 Changes in Clinical Trials Since 2000: Part 2

16 March 2015
by Fiona Hartley About The Author

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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