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Imaging Biomarkers in Clinical Trials

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  • 06 Jul
Imaging biomarkers are currently a “hot topic” in pharmaceutical circles. This was brought into focus at a recent symposium in Princeton and repeated in Amsterdam on “Current and Innovative Imaging Biomarkers in Neurology and Oncology Drug Development.”At this symposium, BioClinica brought together several leading experts and key opinion leaders to present on emerging imaging biomarker trends. Cornelis van Kuijk (Professor and Chair Department of Radiology, Vrije Universiteit Medical Center, Amsterdam) provided an informative introduction to imaging biomarkers in clinical trials. He started off his presentation by saying: “Imaging biomarkers should reflect disease activity and are used to study natural course of disease and to study interventions for treatment such as medication.”
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Best Practices for Applying Electronic Signatures When Using EDC

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  • 01 Jul

Electronic Signature Application Questions

There is quite a bit of information by the FDA and others about what it means to apply an electronic signature.

Here are the questions around electronic signatures that I hear most often:

  • Should the electronic signature be applied to all pages in the electronic CRF?
  • Should the electronic signature be applied to Adverse Events, and Study Completion as typically done on paper? 
  • Should electronically transmitted laboratory data be electronically signed?
  • What happens if pages are electronically signed and the data changes? 
  • What if a page is electronically signed, then a query is added to the page?
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Quantitative Imaging Biomarkers Alliance

Improving the Use of Imaging Biomarkers in Clinical Trials

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  • 30 Jun
One of the areas I spend time on is attending working groups and scientific meetings designed to improve the use of quantitative imaging biomarkers in clinical trials. One such group is the Quantitative Imaging Biomarkers Alliance (QIBA) that is organized by the Radiological Society of North America (RSNA). Established in 2008, QIBA includes representatives from pharmaceutical companies, imaging equipment manufacturers, government agencies, professional societies and clinical trial centers.
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Technology for Clinical Trial Supply Planning

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  • 25 Jun
The 2010 Optimizer User Conference recently ended and I am happy to report a surge in discussion around technology for clinical trial supply planning. I think this speaks well to the growth of the Optimizer product and greater acceptance of the application of more sophisticated tools to the clinical supply planning process in general. There were a number of roundtable discussions and open training sessions, which were as valuable for me as I believe they were for the attendees.
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