Standard SOP Set
New Global CRO Network
Health Decisions launches a new global CRO network that requires certification in its practices.
Are there truly singular contract research organizations (CRO)? Or are CROs interchangeable, like airlines? It's not an academic question in an era when drug, biotechnology and device firms are offloading large and sacred clinical programs to outside firms. The work done by every CRO—science—is driven by government regulations that permit little deviation from international norms. And the frequency with which sponsors hire and fire CROs would suggest that everything can be reduced to the lowest quoted price, or to deals hammered out by two colleagues who trust each other. Pfizer Win But there is an intriguing counter-example in Parexel. The Waltham, Mass. firm has 10,300 employees and $1.3 billion in annual revenue. It has walked a different road in ways that initially made Wall Street nervous. Some of the analyst head-scratching has stopped in the wake of last month's announcement that Pfizer had selected Parexel as one of two preferred providers.…more...
The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials. Should the agency implement and finalize…more...
By design, electronic data capture (EDC) systems are utilitarian. Clinical data managers need a secure, electronic way to collect and change medical information. As such, EDC systems are about as scientific…more...
Given the highly cautious, risk-averse nature of the people purchasing clinical trial services, one might expect a rough launch for a new imaging core lab in San Antonio, Texas. …more...
Whenever we publish anything about imaging core labs, it seems, a good Samaritan rushes forward to point out all of the room for improvement in our previous articles. It's moderately discouraging on one level, but always nice to hear from interested readers. This is our third recent article on the topic. If you're running an imaging core…more...
What are appropriate turnaround times as images pass through the different stages of a clinical trial? Is the pharmaceutical industry applying outmoded thinking? Here's the context for such questions. A few weeks back, we ran an article on benchmarks in imaging. In brief, Perceptive Informatics, a division of Parexel, had adopted some standards in consultation with a…more...
Last Friday, we wrote up the recent Drug Information Association (DIA) presentation by Quintiles VP of global data solutions, Thomas Grundstrom. But the ground rules of the DIA meeting bar speakers from self-promotion or advancing the messages of their employers. That left us with a few unanswered questions. Grundstrom was happy to address those in a conversation…more...
Earlier this month, we ran a two-part series about electronic data from the perspective of clinical sites. (The stories can be found here and here.) The frustration at sites is real. It’s deep. Given that industry urgently needs both EDC and clinical sites, the distress is likely to continue. None of the design constraints—on sponsors or on…more...
Health Decisions launches a new global CRO network that requires certification in its practices.
Trianz, a business process and consulting firm, has bought Afferenz, a lesser-known but powerful eclinical company.
An annual round up of who caught our eye on the exhibit floor at DIA.
PhRMA is trying to help the industry understand and tap the potential of systems for electronic health records.
i3 Global, a CRO, has made a major investment in eclinical technology. Its system could replace four or five pieces of software.
Patti Devereux Gaves says Oracle Clinical’s low profile in the eclinical space will soon change.
What “eclinical” should mean or might mean. An attempt at a definition. And a dietary adventure.
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