Lax Trial Oversight
July 07, 2010
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...
Converging Data Challenges
June 10, 2010
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...
Getting Registries In Sync
January 27, 2010
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...
Our How-To
January 12, 2010
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...
FDA, EMEA Collaborate
Starting in a few weeks, FDA and EMEA will work together on GCP inspection issues. Their call to the sponsor community.
CRO Inspections
With Schedule Y-1, outsourcing firms (and executives) in India have new forms to fill out.
A Quick History
From 1940 to the present, India’s regulations have evolved and affected its clinical research landscape.
On Clinical Consistency
Kit Howard of Kestrel Consultants discusses how to implement data standards throughout an organization.
Clinical Cloud
SAS adapts a large, complex repository for web-based usage by small- and mid-sized sponsors.
The Great Sync
It’s auspicious. Suppliers of clinical trial systems and physician systems are integrating their software. An exclusive chat with Landen Bain.
Finding Quality and Speed
Not sure how to choose an IRB? We’ve got a list.
