How to Create an Effective Risk-Based Monitoring Plan

How to Create an Effective Risk-Based Monitoring Plan

  We recently wrote about how implementing a risk-based monitoring (RBM) plan can improve clinical trial performance with clearer data, fewer site visits, lower costs and improved patient safety. Here, we go into more detail about how best to create an RBM plan to enjoy these benefits. What to Do Before Writing the Risk-Based Monitoring […]

How to Prepare a Successful NDA Submission

How to Prepare a Successful NDA Submission

This post highlights the key considerations — from gap analysis to securing a partnership with the right CRO — for a successful NDA submission to the FDA.