Ethics of Safety Studies for Marketed Drugs

Ethics of Safety Studies for Marketed Drugs Even the Average Joe couldn’t have missed the discussions regarding the safety risks of Avandia.  FDA is again in a tough spot and looking for answers.  Traditionally, Industry was not to make safety claims about drugs, just...

MAGI’s Clinical Research Conference – 2010 West in San Fran

Operations – Regulatory – Contracts – Budgets This year, MAGI is expecting a large increase in attendees…up 50% over last year to a record 600 attendees.  This conference is for study sponsors, research sites, or CROs  in a corporate, academic...

It’s really not that hard

Staying in compliance with procedures and Regulators…It shouldn’t be that hard.  You write up the way you will run your business based on regulations and industry practice and you run your business that way.  What’s the problem?  Creating the system is mundane, but...