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Food and Drug Administration (FDA)

Why hasn't the FDA more actively promoted CDISC standards

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  • 18 May
It has always been a mystery to me why the FDA hasn't more enthusiastically embraced and offered incentives for NDA submissions to conform to the CDISC standards (A bit of this mystery was lifted for me at the CDISC INTRAchange in March). The INTRAchange is a meeting of the core CDISC participants and Dr. Theresa Mullin, Director of Planning and Informatics at FDA/CDER, spoke about the data review process at the FDA. The FDA uses their Janus software as a repository to store the data, but they allow the reviewers to use different end-user tools to generate their views or develop their own code for analysis purposes.
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Eyjafjallajökull volcano in Iceland – Has this volcano affected your clinical trial?

Multinational Clinical Trials vs Mother Nature

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  • 17 May

We all know someone who has been impacted recently by the ash from the Eyjafjallajökull volcano in Iceland.

Source[01]: Wikipedia, photographer: Henrik Thornburn

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Integrating Clinical Trial Data to Bring Products to Market Faster

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  • 14 May
All clinical trial data is digital. We have to submit it to the FDA in a digital manner but it currently gets there in a disparate manner with many systems involved. What is needed to bring products to market faster is what is now known as a "clinical ecosystem." This was something I wrote about before this great term was coined. The concept is that new product development can take place faster through the ongoing integration of electronic data within a clinical ecosystem.
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Risk-Based Monitoring Technology: 5 Essential Capabilities

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  • 27 Jan

If you've spent time researching risk-based monitoring (RBM) over the past year, you know dozens of academics, CROs, clinical trial practitioners, and statisticians have proposed varied approaches based on sponsor needs and trial designs. Unfortunately, despite an abundance of theoretical perspectives on RBM, clinical trial teams soon discover a significant gap still exists between perspectives and actual tools to enable real-world RBM implementation.

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Time to Take Action and Make Risk-Based Monitoring a Reality

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  • 19 Jan

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

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What’s New with CDISC Standards?

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  • 16 Dec

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

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Evolution of the Clinical Data Management Role, 1994-2014

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  • 09 Dec

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

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