Sex, Not Gender, Please
November 14, 2008
It had been a while since we checked in with Rhonda Facile—a renewable energy source who leads one of the most cutting-edge projects in the pharmaceutical industry. She’s the Clinical Data Acquisition Standards Harmonization (CDASH) project director at the Clinical Data Interchange Standards Consortium (CDISC).
CDASH is an effort to get clinical trial data standardized from the…more...
EDC Plays Defense
October 14, 2008
Anyone who attends a certain number of pharmaceutical industry conferences runs the risk of slipping into autopilot mode. One may hear an unrelenting chorus of the same phrases: process change and talk to the agency early and it’s important to communicate and involve all members of your team…. Those phrases can become a sort of Musak heard…more...
Several NIH Projects
February 26, 2008
The pharmaceutical industry is seemingly in agreement that electronic data capture (EDC) is a good idea. Even obligatory. But let’s back up: what is EDC? Is it software? If so, why can it cost hundreds of thousands of dollars to get every trial started? Is EDC more properly considered a service? Then why don’t some contract research…more...
Cellular Synthesis
February 19, 2008
Simplicity is precious. Its absence is irksome. We spent the past week (unsuccessfully) troubleshooting one Microsoft networking glitch. Microsoft engineers are trained to camouflage their messes as simplicity.
Google engineers have a different approach. They deliver simplicity. Google can send its web-based Google Calendar alerts to mobile phones with no configuration.
Exco InTouch appears to have drawn…more...
Firm Boasts 5 Approvals
PHT Diary Bookings Rise
The patient-reported outcome company’s chief, Phil Lee, discusses why his firm is thriving and electronic diaries are so popular.
When Speed Means Slow
Rozwell on Data Standards (Podcast #1)
Gartner distinguished analyst Carol Rozwell talks about drug safety, contract research organizations, data mining and other topics related to CDISC standards.
‘Conservative’ FDA, Frets Ruffolo
Redefining Productivity At Wyeth
In a wide-ranging presentation in Virginia, Wyeth research chief Bob Ruffolo described his own company’s impressive gains in scientific productivity—as well as worrisome trends in Washington.
Competitive Hires
Omnicomm Emphasizes Price, Service
The Florida company wants to play in the big leagues. Stephen Johnson, a former Oracle Clinical executive, talks about his company’s advantages.
Welcome Death To PDFs?
FDA Explores ODM-Based CRF Data
The FDA has announced an intriguing pilot project to explore moving away from PDF-based case report forms. It’s not too early to think about whether your own SOPs and technology infrastructure can readily support the CDISC ODM standard.
EDC 'Not Panacea'
SAS-centric Majaro Clinical Tools
The founder of a SAS-based clinical data management system talks about clinical data management and standards.
Validated Collaboration System
New Document Management Tool
Target Health, a technology-oriented contract research organization, has a new web-based program for document management in regulated industries. It’s called Target Document.
