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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

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

EudraCT: An Introduction to the European Clinical Trials Database

Posted by Fiona Hartley on Aug 20, 2015 2:58:43 PM

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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Topics: CDISC, EUdraCT, Services

Instant gratification is everywhere. Are clinical trials ready?

Posted by Fiona Hartley on Aug 7, 2015 12:27:04 PM

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

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Topics: CDISC, End-to-End Clinical Trials, Services, Training

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

Posted by Fiona Hartley on Jul 23, 2015 2:48:00 PM

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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Topics: CDISC, Define-XML, SAS, Services, Submissions

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

Posted by Fiona Hartley on Jul 10, 2015 10:36:51 AM

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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Topics: Formations, On Demand Services, Services, Software

Our Clinical Trial Predictions For 2015

Posted by Fiona Hartley on Dec 18, 2014 4:38:44 PM

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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Topics: CDISC, Outsourcing, Pharma, SDTM, Services

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

Posted by Fiona Hartley on Jul 30, 2014 9:21:30 AM

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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Topics: CDISC, Conferences & Events, Outsourcing, PharmaVOICE 100, Services

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