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Results for: White Papers - High-quality studies - Our Expertise
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Methods Matter
July 18, 2011
As healthcare decision making becomes more complex, stakeholders are demanding real-world evidence tailored to their own individual needs. -
Clinical Endpoint Committees
February 22, 2011
As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs. -
Is a REMS Request from FDA More Likely for Drugs & Biologics Indicated for Pediatric Use?
October 8, 2010
Is a REMS Request From FDA More Likely For Drugs and Biologics Indicated for Pediatric Use? -
Regulations for Clinical Studies in Pediatric Patients in the European Union
March 10, 2010
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric
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