Jason Baumgartner of BEKhealth Corporation Talks About The Current State of Research Operations in a COVID World with TrialSite
Jason CEO of BEKhealth Corporation talks with TrialSite about the current state of research operations in a COVID world. How COVID has impacted researcher capacity. How technology is improving patient pre-screening and enrollment. How sites can implement new technologies to alleviate manual processes and see more patients.
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The Provenance Gap: Why Real-World Data Passes Technical Review and Fails Regulatory Review
The Provenance Gap: Why Real-World Data Passes Technical Review and Fails Regulatory Review A dataset arrives. The technical review goes well. Field completeness is high. Record counts meet the requirement. The mapping runs cleanly. Everyone signs off. Eighteen months...
What ICH M14 Changes About How Sponsors Choose Real-World Data Sources
What ICH M14 Changes About How Sponsors Choose Real-World Data SourcesReal-world data sourcing used to happen after the protocol was written. A team defined the research question, drafted the design, then went looking for a dataset that could answer it. Procurement...
What Makes Real-World Data “Research-Ready”? A Fitness-for-Use Framework
What Makes Real-World Data "Research-Ready"?: A Fitness-for-Use FrameworkEvery real-world data (RWD) source looks strong on a slide. The patient counts are large. The therapeutic areas are broad. The logos are familiar. On paper, one dataset looks much like another....
Speed, Accuracy, and Trust in Real-World Evidence: A Researcher’s View
Speed, Accuracy, and Trust in Real-World Evidence: A Researcher's ViewReal-world evidence is only as good as the data behind it, and speed, accuracy, and trust are usually treated as trade-offs. A researcher working with the BEKnetwork recently described what it looks...