European Perspectives

UBC - May 27, 2014
Many sponsors utilize registries and observational studies when gathering real-world evidence in the post-marketing environment. When designing and implementing these effectively, the technological platforms supporting should not go...
UBC - May 13, 2014
Every day, sponsors are challenged to ensure patient safety and meet complex regulatory requirements. Increasingly, sponsors of all sizes are collaborating with trusted outsourcing partners to assist with pharmacovigilance. Such...
UBC helps design and implement natural history of disease studies
UBC - April 28, 2014
In-depth study and understanding of the disease or condition for which a drug or biologic is being developed is essential to the scientific foundation of any clinical development program.  That’s why incorporating a natural...
UBC offers electronic data transfer to FDA
Michael Jacquinto, Sr. Manager, Pharmacovigilance - April 24, 2014
Pharmacovigilance reporting is governed by a strict timeline.  Unexpected fatal or life-threatening expedited clinical trial individual case safety reports (ICSRs) must be submitted to the FDA and other regulatory authorities as...
Barton Kelecava, Creative Director - April 22, 2014
We all know that there are many things that are essential to the success of a clinical trial. But there’s one thing that absolutely no trial can do without: Patients. Recruiting patients and equipping trial sites with what they need...

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