May 26, 2019crf

DIA Web Seminar

FDA Pushes For E-source

March 03, 2011

Late last year, the FDA released a draft guidance on electronic source, or "e-source." It's not as exciting as rebelling Libyans or Charlie Sheen's rants, to be sure. But the ramifications are far-reaching, and could impact bread-and-butter monitoring work that is the lifeblood of major contract research organizations (CRO). The agency's official goal is modest. It is merely seeking to augment its previous recommendations about software and clinical research. Specifically, it has been thinking about electronic data and documents in clinical trials. In brief, the FDA is attempting to guide the pharmaceutical industry and the medical research community toward something that might resemble modernity. New Guidance Modernity will not come easily. Many veteran clinical trial professionals belong to pagan support groups that worship paper—small, piled shrines of copier paper, according to most reports. That attachment to paper is a lamentable byproduct of all the problems that electronic systems for clinical research…more...

The eSource Fiasco

What Is An eCRF?

February 03, 2011

"Source" or "esource" could be on the grapevine this year, as sponsors scramble to determine if their systems comply with a new draft guidance from the FDA. It was issued in…more...

Clinical Cockpits

Better Clinical Data Aggregation

January 05, 2011

In 2011, with electronic data capture (EDC) systems in broad usage, there is only one deep question about the technology that remains. To wit: should EDC be confined to merely gather…more...

Covance Case History

Six Sigma and CRF Pages

November 04, 2009

Lean sigma. Six sigma. Lean six sigma. They are buzzwords in the pharmaceutical and contract research organization (CRO) industries, with executives tossing around “black belt” and “green belt” references at conference…more...

Sex, Not Gender, Please

CDASH Case Report Form Push

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

Paper Is King! Long Live Paper!

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

Open Source EDC From Akaza

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

Exco InTouch: SMS Goes Clinical

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.

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