Blog
China now accepts clinical trial data from other countries
China announced earlier this month that it will begin accepting clinical trial data from other countries, Outsourcing-Pharma.com reports. The new guideline, issued by the General Office of the Communisty Party of China Central Committee and the General...
Gretchen Bowker will lead a Purdue Foundry Shakeout Session on working with regulatory agencies
Join Gretchen Bowker, co-founder and COO of Pearl IRB, on Wednesday, October 25 2017 for a Purdue Foundry Shakeout Session. The Shakeout Session, which runs from 12:00 - 1:30pm EST, is titled "Working with Regulatory Agencies." Bowker will discuss working...
Will FDA search for more informative clinical research change the definition of evidence?
Recent comments from FDA officials and industry leaders suggest a shift in the conceptualization of what constitutes reliable clinical research. Data used to make regulatory decisions may soon be pulled from non-traditional data sources outside of standard...
Diana Caldwell will deliver TED-style entrepreneurship talk at HBA-IN Healthcare Development Unconference on 9/29/17
Diana Caldwell, President and CEO of Pearl IRB, will speak about entrepreneurship at the Healthcare Businesswomen’s Association– Indiana Chapter (HBA-IN) event, the Inaugural Healthcare Career Development Unconference. Diana will share details of her...
Complexity and volume of clinical trial exclusion criteria cause for concern
Clinical trial exclusion criteria have increased nearly 60% over the past three decades, according to a recently published study. The steadily increasing exclusion criteria may decrease the likelihood of successful trial completion and generalization of...