February 4, 2012ClinOps

thumbnail
$450K Per Change

Protocol Amendment Costs

June 29, 2011

There is a noble tradition at the Drug Information Association (DIA) conferences. Presenters never speak of money. The assumption is that industry-sponsored research is so exalted that dollars and euros need never be mentioned. Rather, it would seem, large sponsored clinical trials are fueled by hugs and smiles. At this year’s DIA gathering, however, there was at least one session that departed from that tradition. That session discussed the real costs of changing clinical trials that are under way. The costs of protocol amendments, in both dollars and time, are yet another elephant in a crowded room of clinical trial elephants—chronic, apparently intractable issues. “Protocol amendments are a very large problem for our industry,” says Anne Cropp, executive director at Pfizer. Broad Issue She moderated the DIA session and was blunt about amendments. “They are our solution,” she said, “to poor protocol quality.” The session didn’t explore the origins of bad…more...

thumbnail
NSF Study

Why Do Trials Cost So Much?

May 23, 2011

Clinical research is indisputably expensive. Plenty of small life science companies go bankrupt discovering that. The real question is how expensive trials are. Estimates of clinical research costs almost always draw…more...

thumbnail
Clinical Cockpits

Better Clinical Data Aggregation

January 05, 2011

In 2011, with electronic data capture (EDC) systems in broad usage, there is only one deep question about the technology that remains. To wit: should EDC be confined to merely gather…more...

thumbnail
Soft Skills

Real World Data Management

October 29, 2010

At the 2010 Society for Clinical Data Management meeting in Minneapolis earlier this month, one of the most engaging presentations was from Calvin Stewart, a program data manager at Pfizer. He…more...

thumbnail
Amgen’s Expert

Is Project Management ... Strategy?

July 13, 2010

The project manager’s lot in life is not always glamorous and filled with the drama of a James Bond movie. But as with any job in any industry, the project manager’s role in clinical trials has unappreciated complexities that make the role especially indispensible in multi-year projects orchestrated by multiple organizations. Some of the sessions at the…more...

thumbnail
Pfizer Supplier

Kforce On CRA Retention

July 09, 2010

Large life science companies have fired untold tens of thousands of employees during every year of the ongoing downturn—a period of both financial chaos and pharmaceutical mega-mergers. Here's one estimate, and another. Yesterday, having digested Schering Plough, Merck announced it would terminate 15,000 people and close eight research locations. Which doesn't mean the research industry is devoid…more...

thumbnail
Almac's Web Tracker

Smart Supply Thermometers

March 12, 2010

Not all that long ago, shippers of drug supplies for clinical trials were content to know: Did our drug ship? Then they wanted to learn: Did our supplies get stuck in Ukrainian customs—or at the depot? Now Almac Clinical Services is offering another level of detail, allowing sponsors to hop online to learn How long did DHL…more...

thumbnail
Longer Cycle Times

KMR: Industry Contracting Worsens

February 03, 2010

With myriad industry efforts to accelerate study start-up times, one might think the process of hammering out contracts at the site level would now be speedier than, say, three years ago. Wrong. The trends are worsening. According to a new study by consulting, benchmarking and analytics firm KMR Group, the time it takes to get a site…more...

All Sites Benchmark

MCC Goes Sigma

Quality-improvement principles infiltrate metrics in a far-reaching industry collaboration.

Information Overload?

Rethinking Clinical Metrics

Ken Getz of the Tufts Center discusses what the industry is tracking and why.

Covance Case History

Six Sigma and CRF Pages

The contract research organization recounts using process-refinement tools to track CRFs.

Exclusive: Survey

More Paper, More Burden?

The eClinical Forum discusses why sites don’t like the technology the industry spends billions on.

Advanced Math

BioClinica: Why Supplies Matter

The company discusses recent acquisitions in the imaging and randomization arenas.

KMR Data Offering

More Detailed Site Metrics

Learning more about sites could support better trial planning, says KMR Group.

FDA @ DIA

Advisory Committee Selection

More than you might want to know about changes to the process of how advisory committee members are selected.


© 2012 ClinPage. All Rights Reserved.