Profile: Target Health
October 04, 2010
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 pigeons. But they could quote a price on ink and birdseed.
And then there are people like Jules Mitchel, president of Target Health. He delights in…more...
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
To double-check that Phase III protocols are viable before a study starts, sponsors can approach the FDA for a quick sign off.
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.
