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Good Management Practice: Facilitating the Transition from Operations to Project Management: How to Mentor a New Project Manager

A common career change for many people working in clinical research is to move from “operations” into “project management.” For some, this transition may be reasonably gradual; a person may over time take on responsibilities such as managing a work area or part of a budget. For others, the move into project management may be […]

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Data-Tech Connect: The Future of Drug Development is Virtualized and Personalized

Today, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily. Biosimulation (also called modeling and simulation), which integrates computer-aided mathematical simulation and […]

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Operating Assumptions: Operational Mediocrity

Whatever happened to “operational excellence”? It is a beautiful phrase and a worthy goal, but as biopharmaceutical companies and contract research organizations (CROs) start to dismantle or de-fund their Operational Excellence departments, we should ask what is happening. Do we no longer desire excellence? Do we think we have achieved it? Operational excellence arrived as […]

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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 […]