The U.S. Food and Drug Administration (FDA) issued a draft guidance suggesting the agency adopt an International Council for Harmonization (ICH) to a 1998 clinical trials statistics guideline. The original ICH guideline (ICH E9) focused on the use of sensitivity...
Pearl IRB is excited to attend and sponsor the IMDMC Annual Conference tomorrow, November 1, 2017 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the...
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 Office of the...
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...
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 clinical...
