How GDPR is Affecting Clinical Trials

How GDPR is Affecting Clinical Trials

  The General Data Protection Regulation (GDPR) came into force on May 25, 2018 after the European Union determined the need for greater data protection of its citizens, and placed more stringent and standardised requirements on how organizations collect and store data. While the regulations are for the EU, there are implications for companies in […]

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.