FDA, EMEA Milestone

Critical Path Win: New Biomarkers

July 10, 2008

By SuzR

History has been made. The FDA and the European Medicines Agency (EMEA) have reviewed biomarkers together and agreed. For the first time. Ever. That’s according to Raymond Woosley, president and CEO of the Critical Path Institute (CPI), an Arizona-based public-private partnership…

CDASH Webinar Tomorrow

Carbonic e-Case Report Forms

February 13, 2008

By Mark Uehling

The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF). Barely two years ago, CDISC president Becky Kush, the well-travelled and uber-diplomatic Henry Kissinger of the clinical trial realm, located…

Toward One FDA

At DIA, FDA Stresses Electronic Data

March 29, 2007

By Mark Uehling

The recent Drug Information Association (DIA) conference on data management had the usual number of FDA presentations that put many commercial conferences to shame. And one of the most interesting FDA presentations was from Armando Oliva, deputy director of bioinformatics in…

ClinPage Exclusive: Jerry Schindler

The Biostatistical Case For EDC

January 26, 2007

By Mark Uehling

It is utterly impossible to pigeonhole Dr. Jerald Schindler. We’ve tried. Schindler confounds the three easiest caricatures that any self-respecting journalist would reach for. Schindler is a biostatistician, but speaks fluidly, lucidly. He’s a vendor, but leaves his Cytel sales pitch…