FDA, EMEA Collaborate
Bilateral GCP Inspections
Starting in a few weeks, FDA and EMEA will work together on GCP inspection issues. Their call to the sponsor community.
In a new survey of 598 investigator site personnel, there is an unhappy snapshot of the most oppressed and disgruntled segment of the clinical trial workforce. According to the survey, clinical sites are aware of using the Internet to collaborate and manage industry research. But investigators and their staff feel the sponsor community is still too prone to use paper-centric processes that the colonial-era John Hancock would have understood. As an electronic document management company, IntraLinks (which conducted the survey with CenterWatchPaper…more...
Late last year, the FDA released a draft guidance on electronic source, or "e-source." It's not as exciting as rebelling Libyans or Charlie Sheen's rants, to be sure. But the ramifications…more...
IntraLinks is a document management firm with a focus on financial services and life sciences—regulated industries that move around electronic and cellulose-based forms. The New York City company is betting that…more...
Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier…more...
Are international clinical trials regulated? By the FDA? By anyone? In gentle language, the U.S. Department of Human Services says that one of its own fiefdoms, the FDA, has been unable to keep up with the rapid growth in clinical research outside America. The push to find clinical trial patients outside the U.S. is not news. But…more...
Not long ago, the Drug Information Association (DIA) and FDA’s two most important divisions, CDER and CBER, held a joint meeting. Its title was less than intuitive: “Computational Science Annual Meeting.” But the goal of the meeting was laudable and significant to everyone in clinical research. The idea was to explore how technology, broadly defined, could help…more...
What do life science companies produce? Medicine? Pacemakers? In truth, those items are often manufactured by anonymous subcontractors. What life science companies really do generate is intellectual property. Data. Content. Satish Tadikonda, the founder, president and CEO of Virtify, says that the content in our regulated industry will increasingly be required to adhere to a variety of…more...
Wondering what the FDA's special protocol assessments (SPAs) are all about, but too afraid to ask? Last year's Drug Information Association's (DIA) 45th annual meeting was especially helpful, as representatives of Bristol-Myers Squibb, GlaxoSmithKline (GSK) and the FDA's Office of New Drugs within the Center for Drug Evaluation and Research (CDER) presented on the topic. An SPA,…more...
Starting in a few weeks, FDA and EMEA will work together on GCP inspection issues. Their call to the sponsor community.
With Schedule Y-1, outsourcing firms (and executives) in India have new forms to fill out.
From 1940 to the present, India’s regulations have evolved and affected its clinical research landscape.
Kit Howard of Kestrel Consultants discusses how to implement data standards throughout an organization.
SAS adapts a large, complex repository for web-based usage by small- and mid-sized sponsors.
It’s auspicious. Suppliers of clinical trial systems and physician systems are integrating their software. An exclusive chat with Landen Bain.
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