The COVID-19 pandemic revealed significant areas for improvement and development within the clinical trial infrastructure and conduct, especially during times of emergency. In particular,...
Burnout is rampant among clinical trial monitoring staff and patients but orchestrating various technological tools into a single integrated platform offers potential relief. Over...
The Food and Drug Administration (FDA) will soon require clinical trial sponsors to submit a plan for improving diversity among clinical trial participants. While...
The FDA 505(b)(2) regulatory pathway for drug approval, which allows applicants to use existing safety data as evidence, continues to grow in popularity. Innovators...
Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are biotechnology firms that offer a variety of services to pharmaceutical and biotechnology...
Innovation is one messy business. It’s much more convenient to talk about it than lowering yourself into its practical execution, which can include long...