June 26, 2019eclinical

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...

Big Pharma = TBTI?

CTMS Transition at Merck

February 29, 2012

We always look forward to the publication of a new TouchBriefings. The British firm's projects delve a bit deeper. TouchBriefings addresses the knottier questions facing the industry. Visually, its articles resemble…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or "esource" could be on the grapevine this year, as sponsors scramble to determine if their systems comply with a new draft guidance from the FDA.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...

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…more...

The Amazon Problem

An Eclinical No-Fly List

July 19, 2010

Earlier this month, we ran a two-part series about electronic data from the perspective of clinical sites. (The stories can be found here and here.) The frustration at sites is real. It’s deep. Given that industry urgently needs both EDC and clinical sites, the distress is likely to continue. None of the design constraints—on sponsors or on…more...

Longer Cycle Times

KMR: Industry Contracting Worsens

February 03, 2010

With myriad industry efforts to accelerate study start-up times, one might think the process of hammering out contracts at the site level would now be speedier than, say, three years ago. Wrong. The trends are worsening. According to a new study by consulting, benchmarking and analytics firm KMR Group, the time it takes to get a site…more...

Swine Flu Boon

Encorium Plugs On

November 12, 2009

Another Encorium deal has bitten the dust. The beleaguered contract research organization (CRO) recently announced that its recent attempt to sell its Finnish subsidiary Encorium OY to an unnamed CRO in the U.S. is scuttled. In a release, the company stated that, on the heels of $8.7 million in new business contract wins thanks to its selection…more...

Exclusive: Survey

More Paper, More Burden?

October 19, 2009

Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. Surprisingly, the survey suggests that the use of paper case report forms (CRF) is rising even amid growing adoption of EDC. While most sponsors are committed to EDC, site staff believe it is forcing them…more...

Sale to Charles River

PPD Acquires, Divests

PPD sells off its preclinical subsidiary and simultaneously buys a small dermatology-focused biotech firm.

'We'll Be #1'

Oracle Eyes Resurgence

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

Dictionary Quandary

5 Definitions of “Eclinical”

What “eclinical” should mean or might mean. An attempt at a definition. And a dietary adventure.

Reorg, New CEO

etrials: Technology Will Be Key

A conversation with Denis Connaghan of etrials, who recently became the new CEO of etrials.

Interoperable Platform

Medidata’s Eclinical Vision

Glen de Vries of Medidata discusses the company’s effort to create an ecosystem for clinical trial software.

CEO Interview

Clinical Integration from etrials

Chuck Piccirillo discusses the company’s strengths and current direction.

IT Help For Sites

TechTeam Gears Up

With a new strategy, publicly traded TechTeam Global begins angling for more clients that need computer support for clinical trials.

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