May 27, 2019cdisc

Data Integration Tool

Quintiles’ Infosario System

August 03, 2010

Last Friday, we wrote up the recent Drug Information Association (DIA) presentation by Quintiles VP of global data solutions, Thomas Grundstrom. But the ground rules of the DIA meeting bar speakers from self-promotion or advancing the messages of their employers. That left us with a few unanswered questions. Grundstrom was happy to address those in a conversation after the conference. Unbeknownst to us, the top contract research organization (CRO) is on the verge of launching a huge new eclinical system to combine all of the major types of data in clinical trials. The system is designed to tackle an Olympian challenge: monitoring and delivering quality in industry-driven clinical projects. Called Quintiles Infosario, the web-based software sounds like it could address FDA concerns about CROs and provide sponsors an integrated view of information about individual subjects and subgroups of patients. We've not seen a demo, but it appears that the system can…more...

Converging Data Challenges

How To Help FDA

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.”…more...

On Clinical Consistency

CDISC For Skeptics

March 18, 2009

More trials. Bigger trials. More technology and services firms supporting each trial. More types of data. More silos. More entrenched egos defending the silos. All of the above should be driving…more...

The Great Sync

Trial-Friendly EHR Systems

February 25, 2009

First they said it couldn’t be done. Then they said there was no business reason for it to be done. Trouble is, Landen Bain went and did it anyway. As liaison…more...

Interoperable Platform

Medidata’s Eclinical Vision

December 19, 2008

Is the word “eclinical” meaningless jargon? A good way for people to pay lip service to the future without actually building it? The people at Medidata Solutions have been trying to lend some definitional and operational clarity to what “eclinical” means. Two months ago, they announced Developer Central, a set of standards to facilitate the connection of…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...

Pondering EHR Access

Relsys: Beyond Clinical Data

September 15, 2008

Today’s news about Merrill Lynch and Lehman Brothers is interesting. Trillions of dollars in mortgage securities that seemed safe a year ago are radioactive. Wall Street thought the risk could be papered over with accounting gimmicks and legal jabbering. That worked for a while. But the tricky thing about risk is that it has a certain scent—an…more...

19 Firms, 9 Categories

Tout L’eclinical Suites

September 09, 2008

Will biotech and pharmaceutical companies demand simpler technology solutions? Will they insist that systems are as easy to snap together as Lego blocks? To explore which services and technology firms might facilitate such a shift, ClinPage decided to compile a list. All of the firms on our list are major providers of clinical trial services and technologies.…more...

Standards Champions

Forward-Looking Systems At NCI

The National Cancer Institute’s Ken Buetow talks about standards and systems in the caBIG project.

Wednesday News Briefs

CDISC Tech Survey

Bulletins about ClinPhone, IBM, drug safety in Arizona, Generex and Axiom.

CDISC, PointCross, Chiltern

Wednesday News Briefs

News bulletins for 10 October 2007

Avandia, etrials, FDA on e-CRFs

News Briefs

News for Tuesday, May 22.

DataTrak, Nextrials, Acunova

News Briefs

News briefs for Friday, May 4.

Marketing Coup

CDISC Certifies ClinPhone & XClinical

The data standards organization has embarked on a more extensive program to give rigor to technology suppliers who claim compliance with CDISC standards. There is no comparable program for sponsors of clinical trials yet.

Clinipace, INC Research

News Briefs

News bulletins for Friday, April 27.

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