Top 3 Attributes That Make an Excellent Clinical Research Coordinator

In the absence of a good clinical research coordinator (CRC), your trial has an increase chance of failing.  The crucial role of the CRC in facilitating the daily clinical ...
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5 Tips for Running an Effective International Clinical Trial

Pharma and biotech companies are always looking for ways to increase market size to help get their drug to those who may benefit.  And, let’s be realistic here, they’d also ...
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3 Key Steps for Optimizing Your Clinical Site Budgeting Process

This blog reviews key concepts in our new eBook, “How to Budget Sites for Clinical Trials”.  Click here to download your free copy. In part II of this blog series highlighting ...
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Why a Poor Clinical Site Budgeting Process Could Be Costing You

This blog reviews key concepts in our new eBook, “How to Budget Sites for Clinical Trials”.  Click here to download your free copy. The breadth of experience and expertise at ...
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Newly Launched FDA Pilot Program Includes Data Sharing

A new FDA pilot program, which allows clinical study result information to be posted on their website, has some worried that an agency who once resisted sharing data and left ...
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Is Adaptive Trial Design the Buzzword of 2018 or the Real Deal?

There is always a degree of uncertainty when designing your clinical trial.  What doses should you test? What is the best population and size of population to study?  ...
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What's New in the Updated FDA Guidance on Electronic Records and Signatures

In June of 2017, the FDA released an updated guidance for clinical investigators, and any other associated parties, that use electronic records and signatures in their drug ...
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What's the Difference Between an Umbrella Study and a Basket Study?

New methods of clinical trial design are thought to allow more patients to participate and test new treatments at a faster rate.  Two relatively new types of studies for cancer ...
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How the Industry Can Help With New FDA Guidance on Generic Drug Development

In order to facilitate timely access to high quality, affordable generic medicines, the FDA has implemented two drug program enhancements with the goal of improving ...
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