Sloppy Quality Management Programs Spell Trouble Down the Line

“We’re always talking about quality, but it’s more than a buzzword,” says Wendy Troccio, a trial regulations and compliance expert based in Chicago. The difference today? More and more trial practitioners “realize you have to have a plan based on standards and federal regulations,” she explains. That said, any effective program must be tailored to […]

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FDA/NIH Final Protocol Template Could Boost Trial Efficiency

A year in the making, the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) just unveiled a final version of a template for investigators to use when organizing clinical trial protocols. Calling it a roadmap for conducting a trial, Center for Biologics Evaluation and Research Director Peter Marks, MD, noted that […]

Kristen Kuzia Perkins, MS, CCRP, Associate Clinical Trial Manager, TESARO

Study Coordinators Want More Respect from Sponsors

While they may not always show it, most sponsors deeply value and respect the work done by study coordinators, says one-time coordinator Kristen Kuzia Perkins, MS, CCRP, associate clinical trial manager at TESARO, an oncology-focused biopharmaceutical company. “Sponsors want to see them as partners in the clinical trial process,” she adds. The problem: “Most study […]

Lysa Triantafillou, Director, Quality Management Office, Social & Scientific Systems, Inc.

How to Turn SOPs into Performance Tools

It bears repeating: Effective standard operating procedure (SOP) development is the foundation for solid regulatory compliance programs from the efficiency and repeatability perspectives, says Lysa Triantafillou, director of the Quality Management Office at Social & Scientific Systems, Inc. Early in her career, Triantafillou abandoned the “SOPs by committee” concept. “It was just a miserable failure […]

Don’t Let Your Job Title Keep You from Being a Clinical Research Leader

Have you reached a point in your clinical research career where you are itching for a change, but feel constrained by factors like not wanting to relocate, or seeing the next position you crave is already filled by someone who isn’t going to let it go anytime soon, or admitting that moving up the corporate […]