Blog
FDA, EMA recommend more efficient approach to drug development for rare pediatric diseases
The United States Food and Drug Administration (FDA) released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases, Outsourcing-Pharma.com reports. FDA collaborated with the...
The Power of LinkedIn for Life Science Professionals – Diana Caldwell to deliver presentation at Purdue Foundry
Join Diana Caldwell, President and CEO of Pearl IRB, this Friday, December 1, 2017 at Purdue Foundry as she discusses "The Power of LinkedIn for Life Science Professionals." Foundry Grounds occurs each Friday and involves conversations, presentations &...
Don’t wine about FDA – Gretchen Bowker will lead regulatory approval discussion with VisionTech
Gretchen Bowker, COO and Head of Quality at Pearl IRB, will discuss the regulatory approval process at the VisionTech Partners meeting on Thursday, November 30, 2017. The event, "Don't Wine about FDA - Regulatory 101 with Pearl Pathways," is open to...
Clinical trial data sources bound to increase and diversify
It should come as no surprise that the volume and diversity of clinical trial data is expected to rapidly increase over the next few years. The proliferation of mobile health tech, real world evidence (RWE), electronic data capture (EDC) systems, etc. in...
FDA issues draft guidance that would clarify and extend ICH E9 guideline on clinical trial analyses
The U.S. Food and Drug Administration (FDA) issued a draft guidance suggesting the agency adopt an International Council for Harmonization (ICH) to a 1998 clinical trials statistics guideline.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...