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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Tips for Preventing Medication Errors in Clinical Trials

The integrity and safety of a clinical trial greatly depends on adherence to the carefully considered and approved administration protocol for a new investigational drug.  ...
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A Rundown on NEW Updates of FDA's Clinical Trial Data Submission Guidelines

In October 2017, an updated version of the FDA’s Technical Conformance Guide (TCG) was released.  The TCG has been around for about 4 years and provides recommendations on how ...
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Common Pitfalls When Submitting Clinical Trial Study Data

Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to ...
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What to Consider Before Conducting a First In Man Trial

Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution. Also known as Phase 0 trials, FIM ...
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Do You Need an IND for Clinical Trials?

Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. ...
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Successful Clinical Trials in Immunooncology Are Just Getting Started

Pictured: The antibody binding domain of nivolumab, bound to PD-1. Image source: Dr. David S. Goodsell of the Scripps Research Institute. Public domain, accessed via Wikimedia ...
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