June 26, 2019Recruiting

Quintiles, Merck

Post-Approval Frontiers

May 08, 2012

Last week’s 2012 Post-Approval Summit had one theme in common with the events of prior years. It’s the flip side to the rising importance of patient registries and observational Phase IV studies. Like it or not, there is diminishing faith in randomized clinical trials (RCT) on the part of the industry and regulatory agencies. So what greets the majority of untold tens of billions of dollars in industry-sponsored R&D is basically a ... shrug. A sigh. At least at the Harvard-located event last week, there was a triumphant trumpet blast to meet the small slice of science that happens after drugs are on the market. All of the speakers at the 2012 Summit were in agreement. They concurred that industry will be reliant on some combination of traditional RCT, registries and healthcare databases. MediGuard Update Quintiles supplied a textbook example of the value of a good database. Quintiles acquired the conference's…more...

Electronic Patient Outreach

Online Ads For Clinical Sites

August 19, 2011

One way to view the media landscape in 2011 is as a society-wide clinical trial for attention-deficit disorder in which 90 percent of the U.S. population has voluntarily enrolled. Working, walking,…more...

The Digital Divide

When Sites Stumble, Soar

June 22, 2011

When it comes to finding patients, the clinical site universe is starkly partitioned. Perhaps one clinical site in twenty is superb, reaching difficult patient recruitment goals. Such sites make industry-sponsored research…more...

Pfizer's Web Experiment

No Site? No PI? No Problem

April 05, 2011

It was a routine IND meeting at the FDA. Just a few low-level agency staffers were expected to attend. Instead, some of the FDA's most prominent, senior scientific and enforcement leaders…more...

High Throughput Screening

Kiosks For Urban Recruitment

July 23, 2010

The recruitment of minority patients is hard under any circumstances. But finding research subjects for conditions with a social stigma is especially difficult. Barbara Gladson is director of the biopharma educational initiative at the University of Medicine and Dentistry of New Jersey (UMDNJ). She gave a fascinating presentation on her work at the 2010 annual Drug Information…more...

Cross Indemnification

Why It’s Your Fault

June 25, 2010

If you're a clinical research site accepting studies from industry, you've probably seen it. The dreaded cross-indemnification clause. It's an increasingly common element of standard contracts. Under cross indemnification, sites take full responsibility if anything goes wrong. That responsibility attaches to the site whether or not a mishap was its fault or the sponsor's. Such clauses have…more...

Not An SMO

AMR: An 18-Site Alliance

June 09, 2010

In the early 1990s, site management organizations (SMOs) began to form. The idea was simple. Sponsors would be happier if they could go to a single company that served as the management headquarters of many sites, instead of having to approach many disparate, individually run sites separately and forge contracts with each. SMOs like Radiant Research started…more...

Site Profile

Veterans-Centric Research

May 24, 2010

Within the sprawling Loma Linda Veterans Healthcare System in Redlands, California, sits the non-profit research arm Loma Linda Veterans Association for Research and Education , and in a corner of its 54,000 square foot space in the hospital, there sits the small Clinical Research Group, hard at work on Phase III and IV projects. The 12-person team…more...

Ethics Study

Rewarding for Recruitment

A Toronto neonatologist looks at the effects of encouraging scientists to recruit patients.

A Biotech Base

BBK: New Los Angeles Office

The patient recruitment firm discusses the opening of another location.

PI Investors

Jacksonville Site

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

Star Quintiles Site

Proactive Piedmont Medical

A site network discusses how it raised the level of its game.

New Perspective

IAPO Seeks Patient Input

A nonprofit consortium wants research subjects involved in trials while they are being designed.

More Trials?

Preferred Ties To Sites

Some of the challenges and thinking behind preferred site relationships

Tech Overload At Sites

Sanofi’s Relationship Overhaul

An update on how Sanofi-Aventis is managing to stay close to sites.

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