The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
Clinical Research: How to Use Risk-Based Monitoring and Clinical Corrective Action and Preventative Action (CAPA) to Ensure Compliance
It’s estimated that the average cost of developing a new drug has increased from $1 billion in 2010 to $1.1 billion in 2012. A big part of the cost can be attributed to clinical research, which typically lasts at least eight-and-a-half years. Given the enormous cost, time, and effort involved in clinical research, sponsors and […]