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The Monday Morning Briefing: Pfizer first with positive "immune accelerator" results

Posted by Fiona Hartley on Aug 10, 2015 11:46:09 AM

Morning!

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Topics: Biotech, News, Pharma

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

The Monday Morning Briefing: Ebola vaccine "100 percent successful" in trials

Posted by Fiona Hartley on Aug 3, 2015 11:02:12 AM

G’day! Would you like the good news first? It’s Monday morning, meaning another working week is upon us. Excellent! The bad? Well, we only have five days of it until the inevitable blasted weekend. Let’s make the most of it while we can, then, and let’s kick things off with the week’s top five pharma headlines.

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Topics: Biotech, News, Pharma

The Monday Morning Briefing: Allergan offloads generics division

Posted by Fiona Hartley on Jul 27, 2015 1:08:40 PM

Good Morning! The weather outside the Formedix UK offices can only be described as a deluge - which is appropriate, given that we’re battling a perfect storm of pharma news today. There’s so much happening! Let’s just get straight to it, shall we?

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Topics: News

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

The Monday Morning Briefing: FDA and Google discuss mining side effect search data

Posted by Fiona Hartley on Jul 20, 2015 11:36:16 AM

Morning! I’m sure you know the drill by now, but in case you don’t: here are the biggest pharma news stories of the week - digested and distilled for your perusal. Enjoy!

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Topics: FDA, News, Pharma

The Tuesday Morning Briefing: Apple's ResearchKit to become a feature in clinical trials?

Posted by Fiona Hartley on Jul 14, 2015 12:42:31 PM

Morning! Here’s what you need to know in the pharma world today:

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Topics: News, Pharma

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

The Tuesday Morning Briefing: Big pharma will supply Greece, despite crisis

Posted by Fiona Hartley on Jul 7, 2015 12:07:38 PM

Good Morning! We hope you had an enjoyable holiday weekend and managed to wring every last bit of fun out of those four glorious days. Of course, you’ll have been far too busy having fun to keep up with the latest developments on Planet Pharma, so we’ve been trawling the weekend’s news to bring them to you. Enjoy!

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Topics: Biotech, News, Pharma

Formedix #DIA2015 Interviews: CDISC Standards Deadline Raises Bar for Japanese Firms

Posted by Fiona Hartley on Jul 1, 2015 2:59:54 PM

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 second, our man in Japan Masahiro Hayashi talks about the country's looming CDISC deadline, and what it means for its pharmaceutical companies.

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Topics: CDISC, Define-XML, Japan, PMDA, SDTM