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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

Formedix #DIA2015 Interviews: With On Demand Services, Formedix is Changing the Face of Clinical Trial Automation

Posted by Fiona Hartley on Jun 25, 2015 4:36:17 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 first, our CEO Mark Wheeldon talks about Formedix On Demand Services and the future of clinical trial automation software.

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Topics: CDISC, Conferences & Events, 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

Mark Wheeldon Discusses CDISC Standards From the Start - Part 1

Posted by Fiona Hartley on Jan 14, 2015 3:12:09 PM

At CDISC International Interchange 2014, Formedix CEO Mark Wheeldon was invited to present and discuss at a session chaired by CDISC's Rhonda Facile and Dr. Rebecca Kush. When he returned, we sat down with Mark to talk about his presentation, and how CDISC standards implementation from day one of a trial can mean time and cost savings through to submission. The slides below accompanied the presentation.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, Pharma

DIA 2014 Sessions: The Evaluation Results are in!

Posted by Fiona Hartley on Aug 28, 2014 3:00:01 PM
DIA 2014 Sessions: The Evaluation Results are in!
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Topics: CDISC, Conferences & Events, Pharma

Four things we learned at CDISC Asia/Japan Interchange 2014

Posted by Fiona Hartley on Aug 19, 2014 11:02:38 AM

Our CEO, Mark, will go to incredible lengths in search of new CDISC knowledge. Last week, he travelled 5,771 miles to attend this year’s CDISC Asia/Japan Interchange in Tokyo. Between all the sightseeing, sushi and sake, he was able to seriously indulge his CDISC otaku side with some of the leading regulatory experts from around the globe. A diverse list of distinguished speakers and attendees participated in what Partha Chakraborty, Asia-Pacific CDISC Coordinating Committee Chair, called a “game-changer in the Asia-Pacific region for CDISC awareness and standards implementation”.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, CROs, EDC, Japan

Outsourcing will change the way organizations think about data, says Formedix CEO - video

Posted by Fiona Hartley on Jul 30, 2014 9:21:30 AM

Speaking at DIA 2014 in San Diego, our CEO Mark Wheeldon told PharmaVOICE editor Taren Grom that the FDA's acceptance of CDISC standards will change the way organizations think about data. He also discussed the increasing role of outsourcing to CROs and Formedix On, the online platform that will allow users to buy discrete, independent services.

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Topics: CDISC, Conferences & Events, Outsourcing, PharmaVOICE 100, Services

Life Science Events. In person or virtual; what works best for you?

Posted by Fiona Hartley on Jan 7, 2014 1:30:17 PM

There has been a lot of debate in recent years about the value of events, conferences and seminars in the life sciences industry. From our point of view, we exhibit several times a year and participate in speaking opportunities at many conferences, but do our customers and prospective customers find them useful?

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Topics: CDISC, Conferences & Events, Standards, Webinars

4 Compelling Reasons to Take the CDISC Journey.

Posted by Mark Wheeldon on Nov 13, 2013 5:03:55 PM

For many years companies have adopted CDISC, in the belief that the only reason to do so was due to an impending regulatory requirement. Regulation has aided the adoption of CDISC standards, but in many cases, we’ve found that this has fueled the legacy to SDTM conversion market and many sponsors have been left wondering where the long term benefit of standardization really lies.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, Define.pdf, Define-XML, ODM, SDTM, Software, Study Build, Study Design