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 ...
Read More

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 ...
Read More

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 ...
Read More

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 ...
Read More

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 ...
Read More

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 ...
Read More

Should You Choose a Small or a Large Contract Research Organization?

Let's say you represent a rather small pharmaceutical research company and you need help in clinical development for your drug candidate.   How do you find a suitable CRO for ...
Read More

6 Characteristics to Look for When Selecting a Clinical Investigator

A CRO always looks for quality investigators.  They are the key to fulfilling the CRO's contract requirements that has come their way and they want to do a darn good job.  So ...
Read More

Why You Should Consider Exploratory INDs As An Early Development Option

“Proof of Concept” (POC) studies can provide “first in man” evidence that a therapeutic strategy has medical merit and therefore commercial value.  Often potential investors ...
Read More