Expert Insights

How to use a Master Protocol to gain Efficiencies in a Clinical Trial

How to use a Master Protocol to gain Efficiencies in a Clinical Trial

The clinical development industry is an ever-changing field. It’s crucial to stay ahead of industry changes and ensure compliance with the needs of health authorities. Experienced medical writers understand the purpose of a trial and work closely with the study team to recognize efficiencies that may impact the study design or the long-term success of the clinical study.

Tips for Successful Medical Device Development and Approval

Tips for Successful Medical Device Development and Approval

For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device development and approval are regulated by the FDA, under the jurisdiction of the Center for Devices and Radiologic Health (CDRH).

Interim Clinical Study Results

Interim Clinical Study Results

Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results  By Karim Ibazatene, Associate Director of Clinical Trials Transparency Right now, imagining that Sponsors would be required to publish the results of their interim analysis before the end...

Navigating GxP Compliance with Remote Access

Navigating GxP Compliance with Remote Access

Over the past year, many professionals in clinical research have had to navigate through uncharted waters and adapt to remote auditing due to the COVID-19 pandemic. While the landscape of auditing has changed, the basics of confirming compliance remains the same. Almost any audit can be conducted successfully while remote if limitations are recognized and managed appropriately. 

How to Use Machine Learning in Clinical Research

How to Use Machine Learning in Clinical Research

Clinical research is very complex, mainly because the questions we answer are almost always multivariate problems, and machine learning can aid clinical researchers in making sense of it.