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In the News: Standardized Submissions — Are You Prepared?

Posted by Fiona Hartley on Jun 30, 2016 12:03:10 PM

Formedix recently attended the DIA 52nd Annual Meeting in Philadelphia, PA, featuring in The Clinical Oncologist Daily show magazine for the initiatives we have put in place to help organizations prepare for the impending FDA regulatory deadline. Read the full interview below with Solutions Consultant Lesley Gordon below.

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Topics: CDISC, Conferences & Events, FDA, Regulatory, Training

Saving Lives, Time and Money At The Same Time

Posted by Kevin Burges on May 17, 2016 1:52:23 PM

I recently took to LinkedIn Pulse to share my thoughts on the challenges organizations face in getting new drugs to market. In this blog, I also explore the initiatives taking place to overcome these challenges and ultimately optimize the drug development process.

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Topics: FDA

The Monday Morning Briefing: Biotech Bubble Debate Rumbles On

Posted by Fiona Hartley on Oct 19, 2015 1:05:28 PM

Morning! Here are the top five pharma news stories you need to know about today.

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Topics: News, Pharma

Controlled Terminology and CDASH

Posted by Fiona Hartley on Oct 15, 2015 4:33:07 PM

Because the focus of CDASH (Clinical Data Acquisition Standards Harmonization) is on data collection, not data reporting, it works a little differently from the rest of the CDISC content standards. Since there is a disconnect between collection and reporting, the point of CDASH is to bridge that gap by showing how data should be collected, minimizing the disparity with reporting.

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Topics: CDASH, CDISC, Controlled Terminology, CRFs, SDTM

The Tuesday Morning Briefing: FDA Bruised but Cruising after Bad News Week

Posted by Fiona Hartley on Oct 13, 2015 9:48:43 AM

Morning! A delightful Columbus Day break has given way to a four-day week. But the pharma world didn’t stop moving just because you took Monday off - here are the most important news stories you might have missed over the weekend.

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Topics: News, Pharma

Eh... What's SUPPQUAL? An Introduction to Supplemental Qualifiers

Posted by Fiona Hartley on Oct 8, 2015 4:12:31 PM

In last week’s blog, we looked at the SDTM mapping process and ended on the cliffhanger of the supplemental qualifier. These tricky little tidbits are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. Let’s look at them in a little more detail.

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Topics: CDISC, CRFs, SDTM, Standards, Supplemental Qualifiers

The Monday Morning Briefing: Nobel Prize Goes to Pioneering Parasitic Disease Researchers

Posted by Fiona Hartley on Oct 5, 2015 12:56:49 PM

Morning! As is fitting for the first Monday Morning Briefing for almost a month, we have roughly a metric ton of pharma news for you. As ever, please remember not to hog the news - share, discuss and retweet at your leisure. Until next week, dear readers!

We’ll start off with a big, breaking story. The 2015 Nobel Prize in medicine has been awarded to William C Campbell, Satoshi Omura and Youyou Tu, The Guardian reports

Campbell and Omura discovered a new drug Avermectin, which has helped to radically lower the incidence of river blindness and lymphatic filariasis caused by roundworm parasites. Tu discovered Artemisinin, which has significantly reduced the mortality rates for patients suffering from Malaria. “The two discoveries have provided humankind with powerful new means to combat these debilitating diseases that affect hundreds of millions of people annually,” the Nobel committee said. “The consequences in terms of improved human health and reduced suffering are immensurable.”

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Topics: News, Pharma, PharmaVOICE 100

9 SDTM Mapping Scenarios to Master

Posted by Ed Chappell on Oct 2, 2015 2:51:28 PM

One of the most puzzling programming problems involves SDTM mapping: mapping datasets from a non-CDISC structure to CDISC SDTM structure.

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Topics: CDISC, Dataset Mappings, SDTM, Supplemental Qualifiers

Homegrown Define-XML vs. Automated Define-XML

Posted by Ed Chappell on Sep 23, 2015 3:12:55 PM

During the SDTM dataset extraction process, some SAS programmers create the SDTM or ADaM Define-XML directly from the dataset metadata used in the SAS file. This has the perceived advantage of automating the Define-XML creation, but it has a fundamental weakness.

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Topics: CDISC, Datasets, Define-XML, SAS

SDTM and Define-XML: Two Separate Standards

Posted by Fiona Hartley on Sep 17, 2015 11:47:06 AM

“You’d be surprised how many people in the industry don’t realize that the Study Data Tabulation Model (SDTM) and Define-XML are two separate standards,” said my colleague Ed in a meeting last week.

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Topics: CDISC, Define-XML, SDTM