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FDA Mailbag: Agency Addresses Monitoring, Study Close Out Concerns

Clinical trial practitioners seeking direct U.S. Food and Drug Administration (FDA) input for specific questions can leverage an online service from the agency’s Office of Good Clinical Practice. While extensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights from some of […]

Special Advertising Supplement: Schulman IRB

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]

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Integrated Clinical Analytics Model to Improve Business and Operational Excellence in Clinical Research

Innovation and technology are driving efficiency and performance in clinical research by changing the way data are captured, monitored, analyzed, and reported. Mobile and Internet-connected medical devices generate large volumes of data in an environment where data science, data discovery, and visual analytical tools are empowering clinical researchers and study teams to improve trial management, […]