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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

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

15 Changes in Clinical Trials Since 2000: Part 2

Posted by Fiona Hartley on Mar 16, 2015 4:28:38 PM

We’re celebrating the 15th Anniversary of Formedix this year. It got us thinking about how the clinical trials world has changed since we've been around: sometimes it feels like little has changed in 15 years, but often it feels like the pace of change is unsustainable. This is the second in our three-part series - part one is here, and part three is here. Read on for part two of our top 15 things that have changed in clinical trials since 2000.

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Topics: End-to-End Clinical Trials, FDA, #Formedix15, Pharma, Submissions

The Monday Morning Briefing: Asset Swaps, New Chairmen and Federal Citations

Posted by Fiona Hartley on Mar 2, 2015 1:09:28 PM

Morning! It's now March (how did that happen?) but Spring hasn't quite yet sprung here at Formedix UK. However, just like permanently-rainy streets of Glasgow, the well of pharma industry news never runs dry. Read on to find out which giants are trading assets and settling in new chairmen, and which treatments are in trouble after being cited by a federal study.

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Topics: End-to-End Clinical Trials, News, Pharma

Mark Wheeldon Discusses CDISC Standards From the Start: Part 2

Posted by Fiona Hartley on Jan 22, 2015 5:43:04 PM

This is the second of a two-part blog discussing CDISC standards from the start with Formedix CEO Mark Wheeldon. If you haven't read the first part yet, you'll find it here. Below are the slides from Mark's CDISC International Interchange 2014 presentation, CDISC: Standards from the Start, which accompany the discussion.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, End-to-End Clinical Trials, Standards

The Monday Morning Briefing: FDA, Ebola, J&J and more

Posted by Fiona Hartley on Jan 5, 2015 1:11:40 PM

Good morning and welcome to the start of another working year! I’m not sure about you but boy, we’ve missed the office over these past 12 days. We’ve been on top of the latest developments in the pharma world, but it’s understandable that you might have been distracted. So with that in mind, here are the five biggest pharma news stories that emerged over the holiday period.

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Topics: End-to-End Clinical Trials, News, Pharma

The Monday Morning Briefing - breaking pharma news

Posted by Fiona Hartley on Nov 17, 2014 11:11:29 AM

Good morning! There’s a tonne of pharma news to get through this Monday - so let’s get straight to it, shall we?

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Topics: End-to-End Clinical Trials, News

Monday Morning Briefing: the pharma news you need to know

Posted by Fiona Hartley on Sep 8, 2014 4:15:52 PM

It's the first Monday Morning Briefing since Labor Day, so today's news has a distinctly darker-than-normal hue. Here are the breaking pharma stories you need to know about this morning.

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Topics: CDISC, CROs, End-to-End Clinical Trials, News, Study Design

Fast and Flexible Standards with CDISC

Posted by Jim Garety on May 26, 2014 9:00:58 AM

Case report forms (CRFs) are not exempt from the watchful eye of standards; they collect data from clinical research studies in a structured fashion. Their credibility exists primarily because they are regulated by peer reviewed standards.

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Topics: CDISC, CRFs, End-to-End Clinical Trials, Study Design

Big Data to Improve ClinicalTrials.gov

Posted by Greg Blincow on Apr 24, 2014 12:34:07 PM

There has been a major focus in the past couple of years on improvements and innovations in the drug development industry. CDISC is a massive contributor to this as its standards continue to help companies regulate various aspects of their clinical trials. This should perhaps be expected from a not-for-profit organization with the goal of improving the collection, exchange and submission of clinical research data, but are the big pharmaceutical companies doing their part to help the cause?

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Topics: CDISC, End-to-End Clinical Trials, Pharma, Standards