Clinipace

While necessary to describe changes to the protocol that significantly affects patient safety, the scope of the investigation, or the scientific quality of the study; the incremental costs of amendments and the associated study delays can be enormous.  Considering internal FTE time dedicated to implementing each amendment, costs or fees associated with protocol language translation, [...]

Continue Reading "The dreaded protocol amendment, avoid the unnecessary" »

Try as we might to avoid finger pointing, we’re all guilty of it when something goes wrong.  Consider the state of our nation’s political environment today. Finger pointing is the norm, and we, as citizens of this great country, suffer from the lack of progress that it causes.
Ultimately, aiming your digit in the direction of [...]

Continue Reading "Avoiding the digit-al blame game within your clinical development program" »

A few days ago Adam Feuerstein of TheStreet.com published a commentary on Targacept’s failure to demonstrate a treatment effect in one of three of its current phase 3 trials {Targacept Trial Tragedy Takeaway: Don’t Trust Clinical Data From India}. While it’s an interesting article, it was a bit strident.
Regardless of your opinion of India, it’s [...]

Continue Reading "CNS drug development has always been a challenge" »

(From David Ranii at the newsobserver.com)
The outlook for the industry that helps pharmaceutical companies test experimental drugs, a mainstay of the Triangle economy, is more promising than it’s been since the recession slowed demand for such services.
Global revenue for contract research organizations is projected to climb 8.3 percent next year, up from an estimated 5 [...]

Continue Reading "CROs’ outlook is best in years - newsobserver.com" »

Here in North Carolina there is a business publication called the Triangle Business Journal. Every year they identify the fifty fastest growing private companies in the triangle region.  It is a local honor to be identified as such, and an honor I share with all of our wonderful employees and clients.  Last year we were [...]

Continue Reading "Clinipace Worldwide Ranked No. 1 on the Triangle Business Journal’s 2011 Fast 50 List #TBJFast50 #TriangleBIZJrnl" »

I often joke with colleagues that “statistics rule the world,” but I have to admit I’m only half joking. In polite society I usually receive a few chuckles when I make this statement, but within clinical research this mantra is an absolute. If your goal is to achieve a definitive conclusion, you must start with [...]

Continue Reading "Statistics rule the world (at least the clinical research world)" »