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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How Early Should Patients be Enrolled in Clinical Trials of an Investigational Substance

Traditional early clinical development programs have utilized normal healthy volunteers of both sexes in an escalating single-dose trial. These trials are often use small ...
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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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Should Phase II Trials Target Only One Population?

In this post, we share why it can sometimes be a good idea to expand Phase II trials. While doing so may seem counterintuitive to most medical affairs professionals, consider ...
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How and Why You Need to Build a Fully Integrated Product Development Plan

The development planning process of a biopharma candidate, balancing scientific strategy with corporate needs is imperative to success. Therefore, biopharma teams need to ...
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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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The Pros and Cons of Using Pilot Studies in the Clinical Research Process

  Not this kind of pilot studying...   Often with the development of a new compound, teams look into doing a quick and cheap pilot study to see if a larger trial with the ...
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The Importance of Assessing ‘Value’ in Early Clinical Development

It is no longer adequate to proceed through the early clinical development phase with just an assessment of safety and tolerance. Many development programs strive to ...
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