July 31, 2010edc, academia, drug safety data mining

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Part Two

Site Pain With EDC

July 09, 2010

Investigator sites accept the need for technology like electronic data capture (EDC). But they remain puzzled about why some problematic EDC solutions are selected by clinical trial sponsor firms that seem indifferent to the operational problems created by such systems. “Sponsors and CROs really need to think about this,” says Christine Pierre, CEO of the 16-year-old site network RXTrials, and founder of Site Solutions Summit. “Vendors shouldn't be chosen based on who had the biggest, glossiest presentation, but rather, what is their product like for the end user? Randomization goes back to the volunteer who 's waiting and waiting and waiting, and maybe even being sent away. Do we really want new trial subjects' first entree to research to go like this?” Sites have multiple concerns about EDC: There's no standardization around how data are recorded. Yes, the Clinical Data Interchange Standards Consortium (CDISC) has been developing standards. Some of those…more...

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Part One

Sites+EDC=Pain

July 08, 2010

Electronic data capture (EDC) systems allow sponsors to gather data electronically. In theory, that should be cheaper and faster. After a decade of gradual acceptance of the technology, all sponsors have…more...

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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. …more...

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Titans In Services, Tech

2009 Master Providers

May 05, 2009

Public or private. Contract research organization (CRO) or technology vendor. If a company specialized in supporting clinical trials, we considered it. It's no surprise: Quintiles is at the head of our…more...

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IT Help For Sites

TechTeam Gears Up

September 12, 2008

Say you spent a lot of money on the latest and greatest electronic data capture (EDC) solution, and the software purveyors came out and set it up and put your staff through training for a day or two, and then ... shook your hand and disappeared. Now what? What to do about help-desk services? What if several…more...

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CRO Seeks Tech

Trio: Poised for Growth

August 04, 2008

Trio Clinical Research Management, a rare contract research organization (CRO)-staffing company hybrid, was going great guns. The company had a 95 percent client retention rate. It had no debt. Both sides of the business were booming. And owners Betsy Brown and Faye Woolf, friends since the 1980s, were happy as clams. Despite being named to Entrepreneur Magazine’s…more...

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Fewer Features & Faster Setup

EDC, CTMS for Biotechs From ACS

March 26, 2008

It had been a while. Years, actually. But Bruce Schatzman, president and CEO of Advanced Clinical Software (ACS) seems to be doing even better than we expected. He started the firm back in 1993. In our last conversation, published here a long time ago, he wasn’t too worried about Oracle. That proved correct. ACS never needed money…more...

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What Would Dennis Do?

7 Questions: Parexel-ClinPhone Deal

February 20, 2008

Little is known. But what’s there is tantalizing. Parexel International has offered to buy ClinPhone. ClinPhone has rebuffed the overture for now. Matters may go no farther. A merger of the two firms, now hypothetical, would change the conventional wisdom about how services and technologies should be combined in clinical trials. A combination of Parexel and ClinPhone…more...

Expert View

How To Think About EDC

Bayer’s Rob Musterer discusses a little-appreciated aspect of any electronic data capture system.

Less Dictionary-Based Pain

Updated Phase Coding Tool

Updating Central Coding for InForm, Phase Forward tries to simplify the management of vital dictionaries like WHO Drug and MedDRA.

Profile: ProTrials

Seasoned Staff, Tough Projects

The San Francisco firm discusses the difficulty of some of its projects and why it likes more experienced employees.

A Phase IV Push?

INC Research, Medidata Alliance

A leading CRO and trial technology vendor discuss how they work and communicate.

Productivity Enhancement

Nextrials Has Clinical Take On iPhone

Hardly a gimmick, Nextrials’ use of the Apple iPhone could make overworked site staff and monitors like their jobs a bit more.

Savings For MS Registry

Synergies Link Biobanks, EDC

Technology will make new types of clinical collaboration more affordable, says DSG’s Tony Varano.

EDC+ CDMS + CTMS

Clinipace Tools For Data, Projects

With appeal for academia and federally sponsored trials, the North Carolina firm has a solution that combines tools for collecting data and managing trials.


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