Regions of the world hankering to get a robust life sciences business infrastructure going need look no further for guidance than the state of Massachusetts. That’s what the Clinical Research Consortium of Massachusetts (CRCM) is asserting. The new consortium is a group of Bay State-based research-industry heavy hitters coming together…more...

What do a Boston psychiatrist, a Brown University administrator, and a diminutive, legally blind district attorney all have in common? All three believed something was amiss with the marketing of selective serotonin release inhibitors (SSRIs) for children and adolescents. All three serve as the protagonists in Alison Bass’s new book…more...

Even in a global clinical trial, driven by 21st century medicinal chemistry, gene arrays and relational databases, there is a medieval component. A stubborn one. Thousands of pieces of paper, each with a squiggle at the bottom. Signatures. John Hancocks. Squiggles mean the paper has to be pushed like sausage…more...

Microsoft Word documents and Excel spreadsheets are as ubiquitous in the life sciences as in any other industry. In the clinical trial space, the question is: does having trial-related data in non-compliant, non-validated applications present an opportunity or a risk? Can Microsoft programs co-exist or support clinical-trial-specific applications? Or should…more...

The 2008 Drug Information Association (DIA) annual meeting featured a painful session on metrics in clinical trials. Not painful because of any of the speakers, who were polished and insightful. No, it was painful because sizable clinical research projects and sophisticated companies are not really being managed. We’re using the…more...

After PharmaNet‘s (Nasdaq: PDGI) first quarter news that it had again lost $30 million in contracts—the same thing happened to the company in the last quarter of 2007—Standard and Poor’s (S&P’s) revised its outlook on the contract research organization (CRO) from stable to negative. It wasn’t just the loss of…more...

Every two weeks or so, Tim Schroeder gets a call from a fund manager or private equity group wanting to buy Clinical Trials and Consulting Services , the liver and transplant-focused contract research organization (CRO) he founded in Cincinnati almost a decade ago. “They say, ‘Hey, we want to buy…more...

Is there a more wasteful federal program than NASA? Does it matter if a robot can land on some planet and take a picture of itself digging a small hole? It’s clear that NASA is both useless and popular. Which is the opposite of the pharmaceutical industry: indispensible and unpopular.…more...

Independent accreditation in the clinical research world had been slow to catch on, but now it suddenly appears to be a topic of high interest. Compliance with existing regulations is not enough, it seems. Just take the numbers. In its first seven years of accrediting those in clinical research, the…more...

Shouldn’t every protocol be “smart”? It may seem like a rhetorical question. How much of the clinical trial data and budget are truly necessary? Are there ways to simplify the process? As Genentech’s Paul Clarkson, director of data management, explains in today’s podcast, some companies rush to put too much…more...