Stay up to date with the latest news and standards knowledge.

Formedix On Platform Updates: Dec 2018

20 December 2018

It's nearly Christmas and from all of us at Formedix, we wish you a very merry one and a happy new year!

Our present to you in our December release is the fully formed Oracle InForm service as well as our continued work to add clarity and make usability improvements.

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Formedix On Platform Updates: Sept 2018

25 September 2018

We bring to you the latest Formedix On platform release that provides greater usability through user experience improvements, such as seamless viewing of differences between versions of an asset, viewing assets that have been added or updated in a version of a study or standard and usability improvements for viewing and downloading visualizations and exports.  

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Formedix On Platform Updates: June 2018

18 June 2018

The June 2018 update brings some huge improvements to our clinical trial automation platform, Formedix On, giving users complete flexibility and control of their governance processes and change management. In addition, the release history of our products is available as well as various usability improvements.

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

24 May 2018

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

18 May 2018

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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How to Describe Multiple Origins for a Value in Define-XML 2

26 April 2018

There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how to handle data that can come from multiple sources, such as a CRF or eDT. In the simple case you just create a Value List, and specify the Origin on each Value instead of on the Variable.

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Formedix On Platform Updates: February 2018

5 March 2018

In late February 2018, we added new functionality our clinical trial automation platform, Formedix On, to further enhance our users' experience. Improved search functionality for trial assets, a new read-only subscription to view your metadata repository, and improved usability for editing objects such as questions on case report forms (CRFs), are among the highlights of the release.

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Using NCI Controlled Terminology for Standardizing Data

5 February 2018

Use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and ADaM standardize the structures to use when collecting and submitting data, but what about the data values themselves?

This post gives an overview of CDISC's standardized controlled terminology and how it should be used to collect and submit data in a way that speeds trials and enables cross study analysis.

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Using SDTM, ADaM and SEND for Regulatory Submissions

29 January 2018

It's a safe bet that most people's first introduction to CDISC is through the SDTM. This is a content standard that ensures clinical data is submitted in a consistent manner, helping reduce review time and facilitating cross study analysis. Another content standard, ADaM, aims to perform a similar function for analysis datasets. Likewise SEND defines standardized domains for non-clinical data. 

Adoption of these standards is driven by regulators such as FDA and PMDA, who mandate that data must be submitted in these formats.

This post gives a very brief overview of each model, how they fit in with the wider clinical trial process, and how you can get maximum benefit from them.

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Using Define-XML for Dataset Design

22 January 2018

This latest post in our "Introduction to CDISC" series is all about Define-XML. It's known by many due to it being required in regulatory submissions, but why does it exist and what benefits can it bring you?

In the past sponsors submitting to FDA were required to submit a PDF describing their submission datasets.  As we all know PDF is great for viewing on screen or printing, but the information inside it can't be interpreted by a computer in any meaningful way. Enter CDISC's Define-XML model...

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