European Perspectives

UBC helps optimize the value of observational studies
UBC - April 03, 2014
Unlike controlled studies, observational studies have the potential to collect data on thousands – even millions – of patients.  Increasingly, manufacturers are asked for information and data that only these kinds of studies can...
UBC - March 27, 2014
One of the biggest operational challenges with the design of registries, also called post-approval safety studies (PASS), is understanding the differences with clinical trials. Clinical trials involve subjects with very specific...
UBC - March 21, 2014
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UBC - March 10, 2014
As frigid temperatures have taken hold of us in recent months, we can’t help but look forward to what’s ahead. Springtime will hopefully bring with it warmer weather, as well as a new quarter of engaging and informative conferences...
UBC - March 06, 2014
Recent regulatory updates to EMA-mandated PASS requirements and FDA-mandated Post-Marketing Requirements (PMRs) have changed the way safety research is performed. New themes are also emerging for late stage development. As industry...

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