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July 24, 2008
PharmaNet Outlook Down
S&P On CRO Industry
PharmaNet was downgraded from stable to negative by Standard and Poor’s, thanks to $60 million in lost contracts.
Liver Net
CTI: Focussing On Hepatitis
A Cincinnati-based CRO plans to stay medium-sized and private, despite a tidal wave of work that has started to come its way.
Rocket Man
On NASA, BBC and GSK
The industry’s image takes another hit in Britain. Unsolicited advice on avoiding similar encounters.
Sites, IRBs, CROs Lining Up
Seeking The AAHRPP Seal
AAHRPP, which accredits those in the clinical research industry, has standards that go beyond FDA regs.
Little is known. But what’s there is tantalizing. Parexel International has offered to buy ClinPhone. ClinPhone has rebuffed the overture for now. Matters may go no farther. A merger of the two firms, now hypothetical, would change the conventional wisdom about how services and technologies should be combined in clinical… more...
Almost 40 years ago, pediatrician Harry Shirkey called children’s drugs the “therapeutic orphan” of the industry, and unfortunately that still holds true, says Stephen Spielberg, a pediatrician and 30-year veteran of the pediatric drug-development industry. As a rule of thumb, 80 percent of medications for children are not adequately tested.… more...
The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF). Barely two years ago, CDISC president Becky Kush, the well-travelled and uber-diplomatic Henry Kissinger of the clinical trial realm, located ... a replica of herself? In Scandinavia? No, just… more...
If ’s dreams come true, she will soon have Australia’s (and New Zealand’s) clinical trials industry chatting online. Then, in a few years, the entire industry. The former clinical research assistant (CRA) recently launched AccessCR: Clinical Research Information and Resources At Your Fingertips. It’s a portal designed to… more...
Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing the industry, we banged out an email to Scott Evans. He’s a senior research scientist in Harvard University’s School… more...
ProTrials is a boutique contract research organization (CRO) that Jodi Andrews and Inger Arum founded in 1996. Both of them are still running the Mountain View, California, operation together, with Andrews as CEO and Arum as president. A certified women-owned business with 110 employees and contractors, the company is also… more...
In a conference call with Wall Street analysts last week, Parexel chief Josef von Rickenbach outlined some of the company’s recent quarterly earnings and future outlook. ClinPage has this news brief with a few financial results. Elaborating on the press release, von Rickenbach said the dynamics in the contract research… more...
ClinPage recently caught up with Miriam Shuchman, author of the New England Journal of Medicine’s recent analysis of the contract research organization (CRO) industry. Instead of rehashing the NEJM article from October, which still has the industry wincing, we asked Shuchman about the mood in academia. She spoke from her… more...
In a flurry of activity before the end of the year, the U.S. Food and Drug Administration approved two new drugs that—in a historic first for the embattled agency—had been developed internally by FDA scientists. In their spare time, the researchers had been trying to “show our colleagues and friends… more...
The modern clinical trial is built around a 2,000-year tool invented by the Chinese. Paper. Case report forms. Signatures. Binders of paper. Trucks filled with paper. FDA warehouses trembling under the heft of it. Some industries might be ashamed. Not ours. In the life sciences, every self-respecting company can talk… more...
