The Amazon Problem
An Eclinical No-Fly List
Why sponsors should ban hard-to-use systems for clinical research.
As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time. Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring reports? Separate database. Drug safety information? Separate database. The multiple-database approach gave birth to a problem. Suppose a clinical trial manager asked, Is there something that our clinical sites don’t understand about our adverse events? No Answers Such an ostensibly simple question might require heretofore isolated systems to communicate. Which is easier said than done. That apparently simple question could flummox the IT department of a clinical development organization with more revenue than a moderately large Latin American country. Indeed, when the companies paying for clinical trials asked for small databases to communicate, formerly…more...
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…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The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials.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. Intrinsic Imaging was formed at the end of June of this year. Some of its competitors are big, long established and members of the S&P 500. Then again,…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...
Why sponsors should ban hard-to-use systems for clinical research.
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.
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