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 […]
In this post, we explore the advantages of an risk based monitoring study, what to consider when employing this strategy and how the ICH GCP E6 (R2) Addendum mandates it.
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.
This post highlights the clinical research being done by 10 doctors, scientists and researchers whose work may lead to cancer treatment breakthroughs.
This post highlights how trial sponsors and CROs can make more patient-friendly trials and boost the performance of clinical trial sites.
This post highlights how technology can be used to encourage, track and boost participants’ drugs adherence during trials and studies.
This post highlights some advice for creating useful participant interviews, how to ask the right kinds of questions to elicit the most effective clinical trial data.
This post will help you understand best practices, security, compliance, etc that goes into managing your eTMF – electronic trial master file.
Here, we explore the five qualities clinical trial sites most need to have — and how clinical trial directors can go about evaluating them.
Improving the medical coding process itself can save clinical directors significant time, energy and money, while also boosting accuracy. Here’s how.