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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

What can be achieved with CDISC ODM? Standardized libraries of content are just the beginning...

Posted by Ed Chappell on Mar 5, 2014 3:57:16 PM

Recently, there have been comments about the Lilly ODM library no longer being available on the CodePlex website.

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Topics: CDASH, CDISC, CRFs, End-to-End Clinical Trials, ODM

Transform for OpenClinica - all you need to know!

Posted by Greg Blincow on Jan 9, 2014 3:53:29 PM

At the end of last year I wrote a blog post which looked at maintaining standard metadata libraries and transferring this metadata to various EDC systems through our suite of Transform for EDC products . The latest release in this suite is Transform for OpenClinica and I thought I would provide a little insight into the development of this product.

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Topics: CDISC, CROs, EDC, ODM, OpenClinica, Outsourcing, Software

4 Compelling Reasons to Take the CDISC Journey.

Posted by Mark Wheeldon on Nov 13, 2013 5:03:55 PM

For many years companies have adopted CDISC, in the belief that the only reason to do so was due to an impending regulatory requirement. Regulation has aided the adoption of CDISC standards, but in many cases, we’ve found that this has fueled the legacy to SDTM conversion market and many sponsors have been left wondering where the long term benefit of standardization really lies.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, Define.pdf, Define-XML, ODM, SDTM, Software, Study Build, Study Design

Is the Increasing Wave of External Standards Threatening to Drown You?

Posted by Mark Wheeldon on Oct 7, 2013 10:46:57 AM

Pharma, Biotech or CRO - whatever type of organization you belong to, if you are running clinical trials, you will be aware of the number of new standards coming your way. Or are you? And does being aware prepare you for the reality, or putting these into practice?

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Topics: CDISC, CROs, Define-XML, End-to-End Clinical Trials, ODM, SDTM, Services, Software, Submissions, Study Design