January 21, 2019safety

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Labkoff At SAS

AstraZeneca M.D. Maps EHR Usage

May 17, 2012

SAS runs an annual one-day conference about healthcare and the life sciences. With merciful brevity written into its DNA, the meeting can pack its program densely with substance. There is no need for dreaded filler speakers enlisted mostly to accommodate some hotel manager's minimum revenue goal for the event. Steven Labkoff is an example of the sort of presenter that SAS attracted. He’s a cardiologist who is currently head of strategic programs in the R&D information department at AstraZeneca. Labkoff was on a SAS panel tasked with discussing such small matters as the long-term direction of the life sciences and the usage of "big data"—mountains of 1s and 0s in quantities needed by Procter & Gamble or the CIA. Even now, in its infancy, big data has multiple definitions, not all of which may be validly applied to a 50-patient Phase II rhinitis trial. Personalized Emphasis At AstraZeneca, Labkoff said, there…more...

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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…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 trial is a bit murkier. By definition, every trial is one of a kind, with clinical, operational, regulatory and technological aspects that are unique. Having said…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...

Private Equity Buyer

MDS Sells Central Labs

The owners of Chiltern are buying MDS Pharma’s six central labs.

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.


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