Quality Through The Ages

IRT Essentials

Imagine it’s 325 B.C.E and you’re at Aristotle’s school, the Lyceum, in Athens. A builder has come to ask Aristotle’s advice. He explains that his workers have not done well with recent jobs and the customers are finding other builders. He has corrected the issues he’s found in the work but this is costing him his profits for the job when work must be redone. He asks, “can you help me?”

Aristotle ponders for a moment, then says, “Quality is not an act, it is a habit.” And so, we have history’s first formal statement about quality: Quality is not a special, ‘extra’ activity, but a way of intrinsically performing one’s work.

Selecting an IRT

IRT Essentials

One of the most popular features ever published on this website is our white paper How to Choose an IRT for your Clinical Trial. The paper includes a comprehensive checklist of important items to consider when vetting IRT (IWR/IVR) systems.
From time to time we like to spotlight this paper as our current Hot Topic, focusing attention on key issues central to IRT selection, and on the offerings of core functionality that vendor managers and other decision-makers should be sure to consider when comparing systems.

Pharma Quality at Biotech Pricing

IRT Essentials

Earlier this year we attended a conference at which one presenter put up a slide titled, “Pharma Quality at Biotech Prices.” We recall thinking what an odd approach to quality this phrase represents. It could be seen to imply that quality is based on the size of a company and on the amounts spent – i.e., that more is more where quality is concerned. But is this true?

NC Pharma/Biotech Spotlight: Paidion Research

Company Spotlight

With the continued growth of the Pharma/Biotech sector in North Carolina, it’s getting harder to keep up with colleagues and companies. This Spotlight series is part of Veracity Logic’s ‘Howdy Neighbor!’ initiative –a program designed to help all of us who work in North Carolina’s clinical trial industry to get to know the folks in our own backyard!

Once upon a time, in the world of new drug development, the pharmaceutical industry made very little distinction between the conclusions reached in research with adults and the presumptive application of those findings to children. (Sandeep Bavdekar provides a historical perspective on this issue in his article, “Pediatric Clinical Trials” in the 2013 Jan-Mar issue of Perspectives in Clinical Research).

Then the FDA/EMA issued new directives.

North Carolina Authors: Remember Who You Are

Events

In the 1980’s, I had the career-changing experience of taking a job in Chapel Hill, N.C., at a small company called Quintiles, a “CRO” — whatever that meant! — that was about to change the face of pharmaceutical research.