February 8, 2012safety

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Icon's Safety System

With The End In Mind

June 10, 2011

The pace is glacial. But everything the pharmaceutical industry does is becoming more centralized, more standardized—and more electronic. Electrocardiograms (ECGs) are one example. Another is the computer-aided review of endpoints in clinical trials. Icon has been facilitating endpoint adjudication for as long as any firm in the industry, and we recently had a chance to check in with Rafael Escandon, consulting VP of clinical outcome services. Escandon works in the contract research organization's imaging group. The electronic, objective, independent assessment of images, he says, is an area of particular pride at Icon. But the firm's technology and services push has taken him and his clinical endpoint committee (CEC) colleagues far afield from imaging, and into a wide swath of other projects. Says Escandon: "This is a different core service. It's one we've built a dedicated team around." Underappreciated CEC That makes sense. After all, a CEC's blinded work precedes and aids…more...

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CDER Chief On OMOP

Woodcock At Harvard

May 11, 2011

Like those who work in quarries and mines, journalists covering the pharmaceutical industry wear special ear protection while on the job. It's all required by OSHA and has greatly advanced over…more...

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Quantum Leap

Spotless ECGs from ERT

March 14, 2011

It would be hard to find a firm handling more electrocardiogram (ECG) data than ERT. The company handles 9 million ECG data points annually. Not long ago, the firm decided to…more...

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Quintiles At DIA

Toward Quality Trials

July 30, 2010

It’s easy to give a sharp salute to "quality." What modern research organization would oppose it? Quality refrigerators, quality cars, quality overnight packages can be defined easily. Quality in a clinical…more...

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Annals of Drug Safety

Future White House Transcript

June 02, 2010

Editor's Note: Through association with certain spiritual mentalists and accredited acupuncturists, the editor of ClinPage has received what he has been assured is a bonafide transcript from nine years in the future. From the year 2019, to be precise. The transcript below purports to be the byproduct of a U.S. Freedom of Information Act (FOIA) request. It…more...

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Star Quintiles Site

Proactive Piedmont Medical

March 11, 2010

We asked Quintiles to tell us about one of the most improved sites or site networks in its five-year-old partner sites program. The contract research organization (CRO) introduced us to Piedmont Medical Research, a group of 11 sites in North Carolina, South Carolina and Tennessee. The network is based in Winston-Salem, N.C. It's comprised of nine sites…more...

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China Purchase

PPD to Spin Off, Acquire

October 29, 2009

The contract research organization (CRO) PPD unleashed enough news for a year this week. The company announced a long list of new directions, ominous numbers and strategic shifts, including: • The company's quarterly earnings (not great, but not terrible); • The planned acquisition of the Chinese CRO Excel PharmaStudies, which will make PPD a major player in…more...

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Private Equity Buyer

MDS Sells Central Labs

October 14, 2009

The corporate parent of contract research organization (CRO) Chiltern bought MDS Pharma's central labs. Last week, private investment group Czura Thornton agreed to pay $8 million for the labs and an additional $4 million later if performance thresholds are met. The sale is part of Canadian conglomerate MDS Inc.'s continued selling of clinical assets, including MDS Pharma…more...

Tuesday News

Warner Chilcott To Buy P&G’s Pharma Business

News from FDA, Parexel, PPD, Ligand Pharmaceuticals, D-Pharm and Orexigen.

FDA, EMEA Collaborate

Bilateral GCP Inspections

Starting in a few weeks, FDA and EMEA will work together on GCP inspection issues. Their call to the sponsor community.

Top Secret Numbers

India Head Count Sensitivity

Why some CROs won’t say exactly how many feet they have on the ground in India.

Poised for Growth

India Is Hot

In the first installment of our series on trials in India, we look at the upsides, downsides and numbers.

Outsourcing, Inverted

Cheaper Trials At OneWorld

OneWorld explains how it delivers scientific excellence and low budgets in a nonprofit context.

Pharmacogenetic Age

Quintiles Safety Assessment Tool

The CRO discusses its instrument to assess gaps in drug safety risk assessment and mitigation.

Academic Access

WorldCare Enhances System

Imaging CRO WorldCare gets a heavy-hitting CMO and beefs up its in-house system.


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