The Formedix Clinic

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

The Formedix Clinic > Training

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

26 April 2018
by Kevin Burges About The Author

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.

Read More

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...

Read More

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.

Read More

Instant gratification is everywhere. Are clinical trials ready?

7 August 2015
by Fiona Hartley About The Author

There’s much to marvel at - and just as much to dislike - in our culture of instant gratification.

Read More