The Clinical Research industry has long been extolling the virtues, efficiencies and conveniences of Remote Monitoring. Few trials,...

What can sponsors gain from a single Central Data Management team working on their behalf? 1. Functional Core competency in Data...

All regulatory bodies require 100% SDV, don’t they? No, regulatory bodies do not stipulate 100% SDV. The FDA released a Guidance document...

This is a pertinent question, given that we are days away from the requirement for implementation of GDPR.  To put GDPR in perspective,...

There is no doubt that the Data Management function has a unique vantage point in terms of layout and timing of data.  Sites enter one...

The critical need for all trial sponsors today is the access to information in real time.  Should we proceed?  Should we terminate? ...

Would you say the industry has used RBM and adaptive trials to their fullest potential? We are only just at the threshold.  The well...