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...
The notion that a quality clinical trial should be conducted in highly specialized and experienced study centers with tight oversight of patients is becoming...
The ongoing digital revolution in clinical trials has created a daunting new task for the sites conducting the research: managing all the technology required...
Clinical trial sponsors are constantly trying to balance different goals and demands. Ensuring data quality is key, yet clients also seek to recruit diverse...
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...