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Fiona Hartley

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Formedix On Platform Updates: February 2018

Posted by Fiona Hartley on Mar 5, 2018 11:20:00 AM

In late February 2018, we added new functionality our clinical trial automation platform, Formedix On, to further enhance our users' experience. Improved search functionality for trial assets, a new read-only subscription to view your metadata repository, and improved usability for editing objects such as questions on case report forms (CRFs), are among the highlights of the release.

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Topics: Software, Study Build, Study Design

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

Sharing of Data from Clinical Trials

Posted by Fiona Hartley on Sep 20, 2016 5:47:42 PM

In a recent post on LinkedIn Pulse, Head of Product Management, Kevin Burges shares his thoughts on the new rules for data sharing in clinical trials. In his post he highlights challenges that exist in sharing clinical trial data and how these "heartily welcomed" new rules may overcome them.

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CDISC UK Network Update Q3 2016

Posted by Fiona Hartley on Sep 5, 2016 4:42:09 PM

A guest article written by Jenny Griffiths of Roche and Will Stevens of Oxford University, who are CDISC UK Network Co-leads. In this article, they discuss the presentations, breakout sessions and talking points from the annual CDISC UK network meeting.

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Topics: CDISC

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

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

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