December 13, 2017Eclinical

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One Database

Merge’s Unified Trial System

July 12, 2012

As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time. Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring reports? Separate database. Drug safety information? Separate database. The multiple-database approach gave birth to a problem. Suppose a clinical trial manager asked, Is there something that our clinical sites don’t understand about our adverse events? No Answers Such an ostensibly simple question might require heretofore isolated systems to communicate. Which is easier said than done. That apparently simple question could flummox the IT department of a clinical development organization with more revenue than a moderately large Latin American country. Indeed, when the companies paying for clinical trials asked for small databases to communicate, formerly…more...

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Parexel's Goldberg

A New Breed of CRO

June 17, 2011

Are there truly singular contract research organizations (CRO)? Or are CROs interchangeable, like airlines? It's not an academic question in an era when drug, biotechnology and device firms are offloading large…more...

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Clinical Ink's Tablet

New Esource Platform

March 30, 2011

The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials. Should the agency implement and finalize…more...

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Merge Acquires Kika

EDC To Manage Endpoints

February 07, 2011

By design, electronic data capture (EDC) systems are utilitarian. Clinical data managers need a secure, electronic way to collect and change medical information. As such, EDC systems are about as scientific…more...

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Profile: Intrinsic

Central Imaging Labs, v. 2.0

November 18, 2010

Given the highly cautious, risk-averse nature of the people purchasing clinical trial services, one might expect a rough launch for a new imaging core lab in San Antonio, Texas. Intrinsic Imaging was formed at the end of June of this year. Some of its competitors are big, long established and members of the S&P 500. Then again,…more...

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$400 Million Niche

Imaging Core Lab Nuances

September 03, 2010

Whenever we publish anything about imaging core labs, it seems, a good Samaritan rushes forward to point out all of the room for improvement in our previous articles. It's moderately discouraging on one level, but always nice to hear from interested readers. This is our third recent article on the topic. If you're running an imaging core…more...

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7 Questions For Core Labs

Modern Imaging Benchmarks

August 18, 2010

What are appropriate turnaround times as images pass through the different stages of a clinical trial? Is the pharmaceutical industry applying outmoded thinking? Here's the context for such questions. A few weeks back, we ran an article on benchmarks in imaging. In brief, Perceptive Informatics, a division of Parexel, had adopted some standards in consultation with a…more...

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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…more...

The Amazon Problem

An Eclinical No-Fly List

Why sponsors should ban hard-to-use systems for clinical research.

Standard SOP Set

New Global CRO Network

Health Decisions launches a new global CRO network that requires certification in its practices.

Trianz Buys Afferenz

Consultants Buy Eclinical Firm

Trianz, a business process and consulting firm, has bought Afferenz, a lesser-known but powerful eclinical company.

Winner: BioClinica

Best DIA Exhibitors

An annual round up of who caught our eye on the exhibit floor at DIA.

Can Galaxies Merge?

PhRMA Push for EHRs

PhRMA is trying to help the industry understand and tap the potential of systems for electronic health records.

EDC, CTMS, IVR

i3Cube: Trial Swiss Army Knife

i3 Global, a CRO, has made a major investment in eclinical technology. Its system could replace four or five pieces of software.

'We'll Be #1'

Oracle Eyes Resurgence

Patti Devereux Gaves says Oracle Clinical’s low profile in the eclinical space will soon change.


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