December 21, 2014contracts

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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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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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Cancellations Subside

CRO Industry Dynamics

December 02, 2010

Have contract research organizations (CRO) turned the corner? Is the current downturn about to pass? Those were the questions we put to Michael Martorelli, director, Fairmount Partners. Martorelli is a savvy…more...

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High Performance Trials

Lundbeck: Attainable Efficiencies

October 26, 2010

There is one small, nettlesome wrinkle in the way most clinical trials are budgeted. Studies in the same program, therapeutic area or company may not be as similar in cost as…more...

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Clinical Efficiencies

Real Trial Budgets

October 19, 2010

Mike Lange, a senior manager at ClearTrial, is not a board-certified oncologist. But he is breezing through a demonstration of the Chicago company’s software. There is a faux oncology trial on Lange’s screen, and he sets himself the task of finishing a few months early. The software produces rapid, highly detailed clinical trial budgets and time lines.…more...

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Clinical Efficiencies

Abbott: Tighter Trial Budgets

October 12, 2010

There are people who feel clinical trials are artistic endeavors. That the same practices which drive efficiency in other industries cannot be applied to clinical development, any more than efficiency is germane to making a sketch or a symphony. Barry Templin is emphatically not one of those people. Associate director of clinical programs at Abbott Vascular, Templin…more...

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Biotech Focus

Synteract Still Growing

August 10, 2009

The biotechnology sector may be stumbling. Even so, Synteract, a medium/small contract research organization (CRO) that works almost exclusively with biotechs, is doing fine. No, 2009 won't be 2008, when the company experienced 35 percent growth. But 2009 won't be terrible, either. Synteract CEO, president and co-founder Ellen Morgan projects 8 percent growth. “Hopefully, if things improve…more...

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New Network for Spine Studies

Spine-Specific SpineMark

May 05, 2008

Research on the spine is where cardiac research was 10 years ago, declares Marcy Rogers. And that’s why she’s working hard to establish a presence in what she considers a soon-to-boom field. Enter, then, San Diego-based SpineMark CRO Management, the industry’s sole spine-only contract research organization (CRO), launched in 2005 but recently ramping up considerably. Rogers is…more...

Friday News Briefs

DataTrak Revenues Fall

Bulletins about etrials, KGK Synergize, Take Solutions, Huntingdon, PostPath, Qumas and P&G.

Litigation Protection

Clinical Trial Insurance

It may not be illegal to go without a policy in the U.S., but venture capitalists and clinical sites won’t work with sponsors who don’t have clinical trial insurance.

Making Ends Meet

Bridge Loans for Clinical Sites

Thanks to the 140-day delay in payments from sponsors, many pinched clinical sites find themselves in need of a loan. One company out there that understands trials is there to give it to them—for a fee.

Quick Turnaround

Covance On Microdosing

Covance just completed its fourth microdosing trial, and execs with the big CRO think the approach is promising.

Low Interest So Far

Microdosing Update From FDA

Yes, microdosing is part of the FDA’s Critical Path Initiative. But no, sponsors don’t seem to be interested in extremely low-dose trials yet. Why? The FDA’s David Jacobson-Kram offers some thoughts.

Acquisition Factor

Kendle Posts $4.7M Loss

The big picture at the major contract research organization (CRO) remains rosy, with quarterly revenue jumping 78 percent.

4 CROs pick company

etrials Wins 10 New Trials

Most of the new contracts include something besides electronic data capture (EDC): a clinical trial management system, an e-diary, or an interactive voice response system. Some customers are buying etrials’ technology and bringing everything in-house.


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