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The Monday Morning Briefing: Major Blood Pressure Trial Halted Early

Posted by Fiona Hartley on Sep 14, 2015 12:25:57 PM

Morning! With your regular correspondent due to fly out on holiday in just a few short days, this is the last Monday Morning Briefing of September. Better make it a good one, then. As always, don’t forget to comment, like, and share with your colleagues, and we’ll meet again when I return.

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Topics: Biotech, News, Pharma

Paperless Clinical Trials: How Far Away Are We?

Posted by Fiona Hartley on Sep 11, 2015 4:44:50 PM

As recently as a few years ago, manual data collection in clinical trials was the norm.

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Topics: CDISC, EDC, Study Design

The Monday Morning Briefing: Approvals galore - a busy week for the FDA

Posted by Fiona Hartley on Sep 7, 2015 12:40:49 PM

Good morning! We trust you had a happy and safe Labor Day weekend. Sadly, it’s time for the labor to get underway once more, so ease yourself into the week by getting up-to-date with the week’s pharma headlines.

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Topics: Biotech, News, Pharma

3 Things You Should Know About the Analysis Data Model (ADaM)

Posted by Fiona Hartley on Sep 4, 2015 3:02:02 PM

One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate figures, listings and tables more easily, and ensures traceability, which means that reviewers are able to review and approve a submission more quickly.

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Topics: CDISC, SDTM, Standards, ADaM

The Monday Morning Briefing: Amgen's new cholesterol drug gets green light

Posted by Fiona Hartley on Aug 31, 2015 1:08:53 PM

Morning! Did you have fun at the weekend? I did. But now it’s back to the toil - or joy, depending on how you see it - of the working week, and as ever we have the week’s top pharma news stories collected for you. Enjoy, share, and tell us what you think in the comments section below.

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Topics: News, Pharma

Optimizing an End-to-End Clinical Trial in 3 Steps

Posted by Fiona Hartley on Aug 26, 2015 5:25:39 PM

Paris in the summer: a city brimming with life, stunning architecture… and scintillating CDISC discussion. In June, our Consultancy Team Lead Ed flew to the City of Light to meet our technology partners OmniComm and participate in their Collaborative Clinical Insights Symposium. With the focus on achieving operational efficiencies in clinical trials, Ed’s talk focussed on the cost-effective implementation of the Study Data Tabulation Model (SDTM) standard. We sat down with Ed to discuss the standard, and teased out of him three essential steps for optimizing an end-to-end clinical trial.

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Topics: CDISC, Dataset Mappings, End-to-End Clinical Trials, SDTM

The Monday Morning Briefing: Valeant buys "Female Viagra" maker

Posted by Fiona Hartley on Aug 24, 2015 12:38:51 PM

Morning! This week’s pharma roundup has much less in the way of Kim Kardashian news (more’s the pity, right?) and more in the way of pharmaceutical dealmaking, new drug technology, and approval analysis. Read on, and be enlightened.

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Topics: Biotech, News, Pharma

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

The Monday Morning Briefing: Kim Kardashian endorsement lands drugmaker FDA warning

Posted by Fiona Hartley on Aug 17, 2015 1:32:35 PM

Morning! Today’s pharma news roundup is rooted in the fact that the Monday Morning Briefing is no longer a Kardashian-free zone. No matter your thoughts on the world’s most famous (for doing nothing) family, it was always a source of pride for everyone here at the Formedix Clinic that we could provide a haven for those looking to avoid any mention of them: an anti-gossip site, if you will. Sorry, but that’s gone now. Here are this week’s celebrity pharma headlines:

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Topics: News, Pharma

5 Talking Points from the Japanese CDISC Blueprint

Posted by Fiona Hartley on Aug 13, 2015 4:58:47 PM

It’s an exciting time to be involved in CDISC affairs in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) - the country’s equivalent of the US FDA - recently outlined its vision for accepting clinical data in CDISC format for new drug applications, starting in October 2016. And earlier this month, the Agency released its Technical Conformance Guide - the blueprint for CDISC submissions - in English for the first time.

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Topics: CDISC, Japan, PMDA