Compensating patients fairly for participation in clinical trials is not without its ethical concerns. FDA guidance and patient-centricity can ensure just treatment when considering clinical trial reimbursement.
Multinational clinical trials encounter language and cultural barriers. Read on to see how to overcome them and improve study results.
Diversity in clinical trials is not just necessary for reasons of social justice, it can also make study results more robust. Read how you can increase diversity.
Social media is an essential aspect of recruiting and engaging patients for clinical trials. This post explores key considerations when rolling out a social strategy.
An electronic data capture system can make the collection and analysis of data far more efficient and accurate. We explore what goes into an effective EDCS.
Patient feedback is critical: used well, it improves clinical trial designs and patient retention in those trials. We also explore how to get that input.
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 […]
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.