Immunotherapy Will Have A Diverse Impact In Respiratory Disease Trials

Pictured: A schematic of how immunotherapy could be used against respiratory allergies. Published by Sari Sabban in “Development of an in vitro model system for studying the ...
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Immunotherapy’s Clinical Trial Impact In Endocrinology Is Still In Flux

Immunotherapy’s whirlwind of clinical trial successes and failures show no signs of abating.[1] Each passing week finds more immunotherapy trials entered into the ledger, and ...
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What Are the Consequences of Fabricating Clinical Trial Data?

From time to time we hear about situations where investigators are involved with the fabrication of clinical trial data.  Not only is this unethical because culprits are ...
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5 Tips for Evaluating the Best CRO for Your Needs

The trend of outsourcing in both small biotech and large pharmaceutical companies is moving upward.  In fact, Contract Pharma’s 2016 Annual Outsourcing Survey showed that 80% ...
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A Simple Guide to Designing an Effective Dose Response Study

For safe and effective use of new drugs, clinicians need to determine the appropriate starting dose and the best way to adjust dosage to the needs of a particular patient.  But ...
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Are You Ready for a Phase I, First in Human Safety Trial?

So, you have a novel drug ready for Phase I First in Human safety trial.  What dose should you start with that will be reasonable and acceptable to the FDA?  The answer ...
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The Investigator Checklist: What Makes a Good Investigator for a CRO?

When starting a clinical trial for an investigative drug, one of the most critical steps for the CRO is the selection of investigators.  Here are the characteristics we look ...
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Tips for Nailing Your FDA Clinical Meeting

Being awarded an FDA clinical meeting is an exciting indicator of success. Yet, the process and pressure to make it past the meeting can be intimidating. If you haven't ...
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7 Industry Insights for Working with the FDA

As any life science veteran will tell you, much of our industry involves working with the FDA. For this reason, no matter your role in the industry, there's an advantage in ...
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