Darlene Panzitta

Certification Underutilized in Fight Against Technology Aversion and High Turnover

Clinical trial practitioners are far behind the learning curve when it comes to technology—and it’s not their fault, says Darlene Panzitta, president and founder of DSP Clinical Research, a contract research organization (CRO) specializing in services for small to mid-size pharmaceutical, biotechnology, and device companies in such therapeutic areas as infertility, women’s health, male hormone […]

Ryan Bailey, MA, Senior Clinical Researcher, Rho

Arbitrary Age Parameters Can Limit Clinical Trial Efficacy

Turns out age discrimination has spread well beyond the scope of Hollywood actors and hiring in the workplace. “I think there's been a history of picking an age [range] for trials that is [sometimes] arbitrary,” says Ryan Bailey, a senior clinical researcher at Rho. It’s difficult to determine if the problem is getting worse, or […]

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World Health Organization Weighs in on Biosimilar Clinical Trials

In an effort to address lingering confusion, the World Health Organization (WHO) has released a draft Q&A document addressing a number of issues surrounding the development of biosimilars. At the top of its list are the requirements for and duration of clinical trials. “Very little is known about the safety and efficacy of these individual […]

Michelle Hoiseth, Corporate Vice President for Real-World Data Services, PAREXEL

FDA’s EHR Guidance Provides Welcome Clarity to Device Community

Medical device clinical trial practitioners might be under pressure to further raise their game, as evidenced by recent U.S. Food and Drug Administration (FDA) guidance and other moves. “There is a trend in more [FDA enforcement] rigor in devices,” says Michelle Hoiseth, corporate vice president for Real-World Data Services at PAREXEL. Hoiseth sees a number […]

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FDA Guidance Looks to Boost Generic Drug Trials

In an effort to help speed generic drugs to market—especially those addressing the opioid crisis—the U.S. Food and Drug Administration (FDA) has issued 43 new guidances, including 26 aimed at specific drugs and 17 revisions to update and streamline the generic drug trials process. “These updated guidances will make the process for developing low cost, […]