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...
2010 Keynote Address
June 17, 2010
The 2010 annual Drug Information Association meeting began with a new dual-element musical interlude. The first composition amounted to elevator music, by an anonymous band inspired by the hard rock of Van Halen. The purpose of that aural interlude? To inspire and energize.
The second musical offering at DIA, a live string quartet (performers on stage with…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...
In the early 1990s, site management organizations (SMOs) began to form. The idea was simple. Sponsors would be happier if they could go to a single company that served as the management headquarters of many sites, instead of having to approach many disparate, individually run sites separately and forge contracts with each. SMOs like Radiant Research started…more...
All Sites Benchmark
MCC Goes Sigma
Quality-improvement principles infiltrate metrics in a far-reaching industry collaboration.
Rising Star
Medpace Rated Highly
The CRO is loved by sites and has ex-FDA scientists in top executive positions.
Our How-To
Special Protocol Assessments
To double-check that Phase III protocols are viable before a study starts, sponsors can approach the FDA for a quick sign off.
China Purchase
PPD to Spin Off, Acquire
The CRO announces some restructuring of business development.
Tuesday News
India Trials Report
WIth bulletins about DZS, NextDocs, Lab Research, MDS, Phase Forward and India.
Exit Strategy
MDS Pharma To Be Sold
MDS never quite recovered from an FDA audit, and is now trying to sell MDS Pharma Services.
Tuesday News
Warner Chilcott To Buy P&G’s Pharma Business
News from FDA, Parexel, PPD, Ligand Pharmaceuticals, D-Pharm and Orexigen.
