February 4, 2012CROs

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The Waife Approach

Rethinking Change Orders

June 16, 2011

A while back, we ran an article about Joseph Anderson, principal associate at Waife & Associates. He is advocating a new approach to how change orders are handled. Change orders, of course, are ubiquitous invoices for unplanned aspects of a clinical trial. Clinical research is inherently unpredictable. Sponsors frequently decide to change course. Service providers must respond to such changes without being penalized by the financial impact of the new direction. And as a few publicly traded contract research organizations (CRO) have stated in their financial statements, change orders can represent a massive source of revenue. So much so that CROs can anticipate change orders and underbid on their proposals to handle some trials. It's axiomatic that phasing out change orders could send a tremor or two through the financial foundation of the CRO industry. Surprise Me Anderson, to be fair, is viewing the change order almost as a therapist, seeing…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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When Small Is Smart

Omnicare and Specialization

May 05, 2011

By appearances, the services offered by 1,000-employee Omnicare CR are identical to those performed by any large or mid-sized contract research organization (CRO). Omnicare handles the same standard therapeutic areas, the…more...

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Advice from Avoca, Otsuka

On Being Proactive

April 27, 2011

Late last month, in sun-blasted Phoenix, the 2011 Partnerships In Clinical Trials conference featured Denise Calaprice-Whitty of The Avoca Group. We had interviewed Calaprice-Whitty last year, for this article, and had…more...

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Partnerships 2011

CRO Industry Outlook

April 04, 2011

So far, the contract research organization (CRO) industry has been in an enviable place. The fortunes of most CROs have been healthy despite the ailing dynamics of the economy and the major biotech, drug and device firms that hire CROs. All that could be on the cusp of a shift, according to last week's Partnerships In Clinical…more...

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India & Beyond

Why ClinTec Is Growing

March 09, 2011

It's a universal challenge for any contract research organization (CRO). How to standardize complex processes but still remain sufficiently agile to serve customers? It seems to be a test that ClinTec International is passing with ease. President, founder and CEO Rabinder Buttar is a high-profile executive in Scotland, where the firm's headquarters are. Even though her firm…more...

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Appreciating Repositories

Eliassen: Clinical Data Specialists

December 24, 2010

It's a great debate, and far from over. Some analysts predict the large contract research organizations (CRO) will eventually manage the bulk of industry-sponsored research. Others predict that mid-tier and specialty CROs will command a greater share of clinical trials as the giants struggle to take care of small customers as well as they pamper megaclients. Or…more...

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Faux Partnerships

Obituary For Change Orders?

December 01, 2010

Purveyors of clinical trial happy talk would have the industry believe that every clinical trial is an alliance of organizations with the permanence and seriousness of NATO—that every outsourcing engagement is a marriage of equals. Think again, says Joseph Anderson, principal associate of Waife & Associates. The Boston-area clinical trial consultancy specializes in process change and is…more...

Facing Extinction?

The Great Data Debate

A refreshing conference discussion on the future of clinical trial data managers

Schizophrenic RFPs?

PharmaNet On Late Phase

The company discusses what makes Phase IV projects different.

Perceptive & MCC

For Imaging, Standard Metrics

The IT division of Parexel will defer to an industry organization’s definitions for imaging project reports.

Survey Data

Site Solutions Summit

An annual conference enables clinical site leaders to compare notes and share business practices.

Performance, Rewarded

Quintiles Elite Site Program

The top CRO explains how it helps a few sites start 30 percent faster.

FSP Finder

A General Clinical Contractor

Michael Harte discusses a different way of working with functional service providers.

90 Trials Together

Quintiles Alliance with Solvay

Harvard Business Review studies an alliance between Quintiles and Solvay.


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