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
August 17, 2009
Given that clinical trials are conducted globally, couldn't they be regulated in the same manner? That's what the FDA and the European Medicines Agency (EMEA) will explore this fall. The two agencies have just announced they will collaborate for 18 months on a new bilateral good clinical practices (GCP) pilot project.
Leslie Ball, director of the Division…more...
CRO Inspections
July 30, 2009
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...
A Quick History
June 19, 2009
The regulatory system in India is maturing quickly. Just a few years ago, it was said to be in its infancy—with drug makers and contract research organizations (CROs) largely having to regulate themselves. Now it is an adolescent, and growing up fast. To explain where India's been and where it's going with respect to regulating clinical trials,…more...
On Clinical Consistency
March 18, 2009
More trials. Bigger trials. More technology and services firms supporting each trial. More types of data. More silos. More entrenched egos defending the silos.
All of the above should be driving the adoption of the approach of the Clinical Data Interchange Standards Consortium (CDISC). But pockets of resistance to standards remain.
Outside a tight group of CDISC…more...
Clinical Cloud
March 04, 2009
The software that ordinary people prefer is getting simpler. Easier. And it’s increasingly running not on a desktop computer, like Microsoft Word, but online.
Last year, the web ratings firm comScore estimated in this Powerpoint deck that, in the U.S., an impressive 78 percent of users had tried a small, internet program called a widget. Widgets are…more...
The Great Sync
February 25, 2009
First they said it couldn’t be done. Then they said there was no business reason for it to be done. Trouble is, Landen Bain went and did it anyway.
As liaison to health care for the Clinical Data Interchange Standards Consortium (CDISC), Bain has been working for four years to tie together clinical trial systems and the…more...
March 12, 2010
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.
10-Point Checklist
How should regulatory documents and clinical projects be managed? Electronically, says Dirk Beth. Mission3’s approach and a pox on attachments.
A Quickening Process
This emerging market just got more competitive with some new, potentially exciting regulatory changes. The first in a series.
"No Doctor Left Behind"?
In a rare gaffe, Barack Obama’s team mis-routes a confidential strategy memo. A sobering look at what one advisor is thinking.
Silo vs. Life Cycle
The software company is rethinking the way data is collected with the regulatory process in mind.
