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Remote Monitoring Methodologies, Risks and Points for Consideration

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

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Single Central Data Management Cell: The ‘Quality’ Advantage

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

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FAQs: Centralized Monitoring and RBM

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

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What're the implications of the EU’s General Data Protection Regulation (GDPR) on the industry?

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

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What part do you see Data Management playing in this changing tapestry with RBM at the helm?

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...

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How would you say clinical trials have evolved in the last 10 years ?

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

PPCE World

We certainly appear to have the tools on hand that we need for more successful trial outcomes.

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