ClinPage: ClinOps

May 21, 2013ClinOps

Blistering Speed

Almac Adds Pack Capacity

May 22, 2012

Unassuming though it may be, the blister pack is a vital element of the modern clinical trial. In an era of global studies with complex dosages, there are a limited number of firms that can teach a master class in clinical operations or drug supply and make kits at scale. That’s why the U.S. office of Almac recently announced buying a new blister pack-making machine from PharmaWorks, which makes equipment to package life science products for the consumer market. Almac is moving toward industrial levels of speed and efficiency in blister pack production for industry research. The top velocity that Almac formerly could churn out in America was 500 blister packs per hour. Now it can produce 2,000 per hour. Large phase III projects are the ones that the new machine will typically support. The machine can bundle up to four different medications into one pack. Sponsors appreciate the ability to…more...

$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…more...

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...

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...

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 provided a glimpse into the real world of clinical data management from the sponsor perspective. For starters, Stewart said, forget about that newfangled email software you…more...

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...

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...

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...