In December 2012, Pearl IRB published a White paper, “What Could Proposed Changes to the Common Rule Mean to Sites, Sponsors and IRBs?” The Common Rule, also known as the Federal Policy for the Protection of Human Subjects outlines regulatory requirements for human...
The Tufts Center for the Study of Drug Development (TCSD) has released data showing that between 2004 and 2012 the number of endpoints per protocol has increased from an average of eight per protocol in the earlier period to 14 endpoints in the later period. To read...
The healthcare industry, medical research and drug approval process are projected to be greatly affected by the federal budget cuts scheduled for March 1, according to a recent article on mondernhealthcare.com. The Budget Control Act of 2011, originally scheduled to...
IHIF is hosting a lunch panel on April 16th, featuring Pearl’s Diana Caldwell and other industry professionals to discuss the impact of the service sector on life sciences in Indiana.
IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
