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Schulman IRB: Innovative Oncology Research and Participant Protection

Clinical and technological advancements have made it possible to plan groundbreaking oncology study designs and innovative cancer therapies. From a human subject protection perspective, however, these incredible advances also create potential challenges for the research community. Communicating complex scientific and medical concepts and long lists of potential risks—all while the clock is ticking for the […]

The Rise of Electronic Data Capture and its Greatest Obstacle

Advancement in healthcare-related technologies has resulted in a groundswell of information contained in patient health records. Electronic data abstraction systems have allowed medical professionals to analyze and apply vast bodies of information comprehensively. In the field of clinical trial management, electronic data capture (EDC) has become vital to this process. Over time, EDC yields benefits […]

Site Monitoring an Expensive Affair? Not Any More…

As emphasized by the U.S. Food and Drug Administration (FDA),1 European Medicines Agency (EMA),2 and nonprofit organizations like TransCelerate,3 the pharmaceutical industry is well on its way to embracing the shift from classical monitoring practices toward advanced and improved new monitoring practices. Risk-based monitoring (RBM), remote central monitoring, and use of eSource are already popular […]