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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

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

Making Life as a CRO Simpler

Posted by Darren Bill on Apr 2, 2014 3:39:00 PM

Ever feel like your sponsors’ requests are never ending? Are you restricted by the EDC system(s) you work with? Do you long to design studies in one tool and build out to multiple systems more easily? You’re not alone!

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Topics: CROs, EDC, End-to-End Clinical Trials, Medidata Rave, OmniComm, OpenClinica, Outsourcing, Software

Transform for OpenClinica - all you need to know!

Posted by Greg Blincow on Jan 9, 2014 3:53:29 PM

At the end of last year I wrote a blog post which looked at maintaining standard metadata libraries and transferring this metadata to various EDC systems through our suite of Transform for EDC products . The latest release in this suite is Transform for OpenClinica and I thought I would provide a little insight into the development of this product.

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Topics: CDISC, CROs, EDC, ODM, OpenClinica, Outsourcing, Software

Rave? OpenClinica? Migrating studies between EDCs isn't so tough...

Posted by Greg Blincow on Dec 18, 2013 12:03:42 PM

Have you ever found yourself looking for a simple way to transfer your study metadata to an EDC system? This can prove tricky as different EDC systems utilize different import mechanisms, and use a variety of formats, as well as having their own proprietary metadata. To combat this issue, we have created a suite of ‘Transform for EDC’ products which work in conjunction with our data acquisition design tool.

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Topics: CDISC, CROs, DataLabs, EDC, Medidata Rave, OmniComm, OpenClinica, Outsourcing, Perceptive Informatics, Software, Study Build, Study Design

'CRO industry revenue expected to double'...will you be part of it?

Posted by Fiona Hartley on Nov 21, 2013 10:44:50 AM

We all know that the end-to-end clinical trial process is becoming more complex and more heavily regulated, week on week, by authorities such as the FDA. We regularly learn of customers and industry professionals who are outsourcing to Contract Research Organizations (CROs) to undertake their studies, and it is becoming increasingly more popular - around 40% of drug development is currently outsourced.

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Topics: CROs, End-to-End Clinical Trials, Outsourcing, Submissions, Study Build, Study Design

Is the Increasing Wave of External Standards Threatening to Drown You?

Posted by Mark Wheeldon on Oct 7, 2013 10:46:57 AM

Pharma, Biotech or CRO - whatever type of organization you belong to, if you are running clinical trials, you will be aware of the number of new standards coming your way. Or are you? And does being aware prepare you for the reality, or putting these into practice?

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Topics: CDISC, CROs, Define-XML, End-to-End Clinical Trials, ODM, SDTM, Services, Software, Submissions, Study Design