Survey Lessons
J&J on Informed Consent
BBC criticism spurred J&J to look more closely at its informed consent form.
Earlier this week, JNJ said it will buy the Swiss medical device firm Synthes for $21.3 billion. A debased U.S. dollar isn't worth much these days. Still, 21.3 billion of anything remains an impressively tall pile. Uniquely in big pharma, JNJ has a record of megadeals that have been years ahead of peer companies. With numerous semi-autonomous groups under its corporate umbrella, JNJ hasn't made any egregious miscalculations or gotten so big and bureaucratic that it failed to meet Wall Street expectations. As readers know, JNJ was the first big drug company to invest in both biotechnology and medical devices in major ways. So it's interesting that its executives are placing another huge bet on devices, spending a sum equal to a third of JNJ's current annual revenues. Elevated Hopes The deal elicited the usual confident statements from senior management. JNJ's existing device business and Synthes "will create the most innovative…more...
Late last month, in sun-blasted Phoenix, the 2011 Partnerships In Clinical Trials conference featured Denise Calaprice-Whitty of The Avoca Group. We had interviewed Calaprice-Whitty last year, for this article, and had…more...
Organizing a panel at a pharmaceutical industry event is not easy. There is little solid ground for true dialogue, as so many companies are doing the same activity in slightly different…more...
How bad are the job losses in pharma? How long will they last? As a starting point, every month brings new, grim numbers from Challenger, Gray & Christmas, a Chicago firm…more...
If you're a clinical research site accepting studies from industry, you've probably seen it. The dreaded cross-indemnification clause. It's an increasingly common element of standard contracts. Under cross indemnification, sites take full responsibility if anything goes wrong. That responsibility attaches to the site whether or not a mishap was its fault or the sponsor's. Such clauses have…more...
Quintiles has shifted its prime sites program into high gear. A bit more than two years ago, the contract research organization (CRO) had just one site designated as prime, meaning it had reached the top of the heap as a voluminous and consistent source of patients with a healthy smattering of investigators across a variety of therapeutic…more...
Trio Clinical Research may not be in the rapid growth mode it was forecasting last year when its owners sold a majority stake to two equity groups. But things are moving along nicely for the contract research organization (CRO) and research staffing hybrid. Kurt Mussina joined the company as senior VP of business development in March. It…more...
Contract research organizations (CROs) will now have to register with the body that regulates clinical research in India if they want to continue partaking of the boom there. India's Central Drug Standard Control Organisation (CDSCO) has issued Rule 122 DAB on “Registration of clinical research organisations for conducting clinical trials.” After its 45-day comment period, the rule…more...
BBC criticism spurred J&J to look more closely at its informed consent form.
PPD discusses its pending $30 million purchase of AbCRO, a women-owned firm with a strong base in Eastern Europe.
Coast IRB just made Inc. magazine’s list of America’s 5,000 fastest-growing private companies. It’s the only IRB ever to do so.
In Side Effects, reporter Alison Bass delves into the New York Attorney General’s 2004 case against GlaxoSmithKline.
Manhattan-based Clinilabs, started by a sleep researcher, has elected to expand into data management.
The publicly traded Wayne, Pa.-based CRO has posted losses for four straight quarters. Investors are wondering how the company plans to right its course.
BioWorld’s 2008 Executive Compensation Report is out, and, as usual, Amgen’s Sharer ranks highest. But that could change.
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