Clinical Research & Clinical Trial Management | Project Owner

Project Owner is an educational blog covering clinical research, clinical trial management, project management, data quality, regulatory frameworks, Quality by Design, and AI-driven digital transformation. It features tutorials, regulatory insights, FDA and ICH guidance, and practical articles on CTMS, EDC, TMF, Real-World Data, and clinical trial operations.

Top 20 LMS Software from Capterra

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November 08, 2017

https://www.capterra.com/project-management-software/#infographic

https://www.capterra.com/learning-management-system-software/#infographic

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Project Management Software

January 01, 2019

What is a Project Management System or Project Management Software? Is there a common understanding on functionality of such system and if it is needed at all? What systems project managers use for projects? Project Management System should be one to help Project Managers to manage Projects. The word " project " originally meant "before an action" or plan of something. Projects are defined by PMI as Temporary endeavor (having start and end) to create a unique product, service or result. Project managers are to manage timelines, budget and scope. PMI defines 5 process groups (from start to end) and 10 knowledge areas. Project Management Software definition in Wikipedia is vague and open to interpretations: Project management software has the capacity to help plan, organize, and manage resource tools and develop resource estimates. Depending on the sophistication of the software, it can manage estimation and planning, scheduling, cost contro...

Making Unaccounted Costs Accountable in Clinical Research

March 26, 2026

Clinical trials operate under strict timelines, regulatory requirements, and complex coordination between sponsors, CROs, sites, and vendors. When delays occur or issues arise, project teams often resolve problems by working longer hours rather than by adjusting timelines, budgets, or processes. In many organizations, a standard working day is approximately eight hours. However, Clinical Research Associates, Project Managers, and other clinical operations staff may regularly work ten or more hours per day, especially during critical study phases. If only eight hours are recorded in time sheets while ten hours are actually worked, two hours per day become unaccounted operational effort . Individually, this may appear minor. Over the duration of a clinical trial, the financial impact can be substantial. Financial Example: Unaccounted Hours Over a Project Duration

Clinical Research on Hypnosis: Evidence and Applications

June 07, 2025

* This image is produced by GenAI as Illustration, it may contains irregularities. Recently, I came across new research from the University of Zurich that looked at the effects of hypnosis on the brain. I remembered hearing about hypnosis in the past, but I had never followed the subject closely. Like many, I assumed it was something on the edge of science Interesting, but not really part of how we understand the human body or behavior in practical terms. It’s not something you’ll find in a physiology textbook, and it doesn’t fit into the structured way we usually think about biology, medicine, or professional life. What caught my attention this time was the growing number of clinical studies showing that hypnosis can help with real-world problems. Especially sleep, chronic pain, and anxiety. These are not isolated cases. There’s now enough consistent data to suggest that hypnosis has measurable effects, and that it might be underused simply because it doesn’t fit into the usual...