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The Twelve Days of Formedix

14 December 2016
by Fiona Hartley About The Author

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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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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A Unique Proposition for the Outsourcing Market

13 July 2016
by Fiona Hartley About The Author

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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EudraCT: An Introduction to the European Clinical Trials Database

20 August 2015
by Fiona Hartley About The Author

A client contacted us recently with an enquiry about EudraCT XML. Even for the most seasoned standards veteran, that term might be a little obscure. 

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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.

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Who Converts Wins: How to create Define-XML from SAS XPT datasets

23 July 2015
by Fiona Hartley About The Author

When submitting clinical data to a regulator in electronic format, you’ll need to include metadata - data about the data - in the form of a Define-XML. This CDISC-format file helps the reviewer who’ll eventually approve or reject your application by describing the format and content of the data submitted.

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Formedix #DIA2015 Interviews: The End of User Licenses: How Formations Could Revolutionize Software Procurement

10 July 2015
by Fiona Hartley About The Author

Ahead of this year’s DIA 2015 Annual Meeting, Formedix commissioned a series of three interviews with some of our CDISC standards experts. In the third, Consultancy Manager Darren Bill discusses Formations, the token-based payment system for Formedix On Demand Services, and its advantages over traditional user licenses.

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Our Clinical Trial Predictions For 2015

18 December 2014
by Fiona Hartley About The Author

At this time of year, the Formedix office is abuzz with planning for 2015. In an industry as dynamic as clinical trials, it can be difficult enough simply staying on top of the latest developments, never mind predicting the future. We asked our Formedix experts to do just that though, and we present to you their thoughts on where clinical trials are going in 2015.

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Outsourcing will change the way organizations think about data, says Formedix CEO - video

30 July 2014
by Fiona Hartley About The Author

Speaking at DIA 2014 in San Diego, our CEO Mark Wheeldon told PharmaVOICE editor Taren Grom that the FDA's acceptance of CDISC standards will change the way organizations think about data. He also discussed the increasing role of outsourcing to CROs and Formedix On, the online platform that will allow users to buy discrete, independent services.

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

7 October 2013
by Mark Wheeldon About The Author

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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