May 26, 2019data management

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 same typical functional areas of work such as trial setup, project management, monitoring and SAS programming. Appearances, of course, are not always representative of the energetic thrust of a company. James Pusey, chairman and CEO of Omnicare CR, had previously helped turn around a division of MDS Pharma prior to its sale to Inc Research. Last week Pusey helped to finalize the sale of Omnicare CR to investors at Nautic Partners for an undisclosed sum. He'll continue on as the chief of Omnicare CR, which will eventually be renamed to avoid confusion with its former corporate parent, a nursing home chain. Pusey notes that several big CROs were in the bidding for Omnicare, and that Nautic was chosen partly for…more...

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…more...

Facing Extinction?

The Great Data Debate

November 05, 2010

Organizing a panel at a pharmaceutical industry event is not easy. There is little solid ground for true dialogue, as so many companies are doing the same activity in slightly different…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…more...

What's Our Number?

Medidata EDC Enhancements

October 22, 2010

At all large technology companies, innovation dies. Intel, Microsoft, Nokia, Intuit may claim to invent. But year after year, their ostensibly new products are indistinguishable from older ones. Could any ordinary human differentiate between phones or PCs from 2005 and 2010? Which are more glaring: the engineered security holes in Adobe's Flash plugin, or the file synchronization…more...

Profile: Target Health

Ending Mindless Monitoring

October 04, 2010

Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier pigeons. But they could quote a price on ink and birdseed. And then there are people like Jules Mitchel, president of Target Health. He delights in…more...

Compliance? Huh?

Are Academics Competent?

August 05, 2010

History records that after her husband was assassinated, someone asked Mrs. Abraham Lincoln about the theatrical production she had just seen. With all deference to Mrs. Lincoln, we are in a similarly stunned state of mind after talking to Kit Howard, principal of Kestrel Consultants. Based in Michigan, with a Canadian's calm demeanor, Howard speaks in methodical,…more...

Medidata, SAS Alliance

Strong Clinical Data Custody

June 15, 2010

While it supports a cottage industry of professionals, manually pushing piles of clinical trial data along from one system to the next isn't necessarily the most efficient way of doing things. The same company may map data for the same drug in different ways in different trials—or miss errors in one trial's data set that were fixed…more...

Converging Data Challenges

How To Help FDA

A recent conference highlighted a daunting IT situation at FDA, and opportunities for proactive clinical data standards development in the sponsor community.

Site Profile

Veterans-Centric Research

Veterans like to participate in clinical trials, and a top California site knows how to ask.

PI Investors

Jacksonville Site

The best way to keep principal investigators passionate about a commercial research site? Ownership.

Longer Cycle Times

KMR: Industry Contracting Worsens

The time necessary to contract with a site isn’t any faster than three years ago.

Our How-To

Special Protocol Assessments

To double-check that Phase III protocols are viable before a study starts, sponsors can approach the FDA for a quick sign off.

Space Doubles

Quintiles Central Lab Expands

The top contract research organization just expanded in Edinburgh. Next up: Singapore.

Proactive Safety

SAS, GSK At SCDM Meeting

New thinking on how drug safety should be handled and assimilated in a litigious, electronic era.

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