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Using ODM and CDASH for CRF Design

Posted by Kevin Burges on Jan 15, 2018 4:30:00 PM

Over the last few years our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SDTM, SEND and ADaM.

This post shines a spotlight on the lesser known Operational Data Model (ODM) standard, which is often overlooked as it's not required by any regulators. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Finally they can be used to drive your data collection system. In short, they put you in control.

With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to re-use and increased consistency between studies. 

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Topics: CDASH, CDISC, CRFs, ODM, SDTM

An Introduction to CDISC Standards

Posted by Kevin Burges on Jan 8, 2018 4:30:00 PM

Let’s start at the start - what is CDISC? The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization.

Formedix have been strong advocates for the use of CDISC data standards in clinical and non-clinical research for half my life now, ever since we realised how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around use of CDISC standards, and are now industry leaders in CDISC software, professional services and training.

Over the next few weeks we’ll be publishing a series of blog posts giving an overview of the various CDISC models. Our aim is to help you understand how you can make the most of these industry standards. If we all work together using the same standards we can optimize our clinical trials by increasing data quality and reducing design and execution time. Ultimately that means getting more products to the market with less cost.

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Topics: CDASH, CDISC, Define-XML, ODM, SDTM, SEND, ADaM

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

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

Sharing of Data from Clinical Trials

Posted by Fiona Hartley on Sep 20, 2016 5:47:42 PM

In a recent post on LinkedIn Pulse, Head of Product Management, Kevin Burges shares his thoughts on the new rules for data sharing in clinical trials. In his post he highlights challenges that exist in sharing clinical trial data and how these "heartily welcomed" new rules may overcome them.

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CDISC UK Network Update Q3 2016

Posted by Fiona Hartley on Sep 5, 2016 4:42:09 PM

A guest article written by Jenny Griffiths of Roche and Will Stevens of Oxford University, who are CDISC UK Network Co-leads. In this article, they discuss the presentations, breakout sessions and talking points from the annual CDISC UK network meeting.

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Topics: CDISC

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

A Unique Proposition for the Outsourcing Market

Posted by Fiona Hartley on Jul 13, 2016 2:40:05 PM

What makes our offering for Contract Research Organizations (CROs) so unique? CEO Mark Wheeldon shares his thoughts on the growth of the outsourcing pharma market and the exciting developments at Formedix to support the increasing demand. Read the full interview, published in The Clinical Oncologist Daily, below.

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Topics: CDISC, Outsourcing, Services, Software