In this post we provide a step by step direction on how to evaluate the proper dosing levels for your first in human Ph I trial.Read More
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 demonstrate value assessments for the development candidate and along with the pharmacokinetic profile of single and multiple doses. Although it would be developers delight to find a robust treatment effect in their development Phase II program(s) results. Now developers are faced with providing evidence of the value this candidate provides to the world of health care management.Read More
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 your particular needs? What characteristics should you look for among the multiple choices you have in selecting a CRO? Should you go for a large CRO or a small CRO?
Here are some things to consider.Read More
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 do the good investigators, of course. It makes sense for everyone involved including the sponsor. We at ClinSmart have been in all three roles in our respective careers and can vouch for the validity of these facts. So let me tell you what I look for when I'm selecting a principal investigators for a clinical trial we have a contract to fulfill...Read More
“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 and development partners wish to see critical information which provides evidence that the proposed therapeutic strategy will work “as advertised” in man. Traditional drug development strategies require moving a molecule along a proscribed drug development path, often taking several years and multiple investments of millions of dollars to obtain a “first in man” experience. These studies often do not address questions which are necessary to determine that the proposed therapeutic approach will work...Read More