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A bipartisan bill introduced in the Senate would streamline the clinical trials process and expand patient access to experimental treatments. Read More
The Association of Clinical Research Professionals published its final Core Competency Framework for Clinical Study Monitoring, outlining the main skills needed throughout the clinical research associate workforce. Read More
The Association of Clinical Research Professionals and CRO Analytics announced a joint initiative to provide clinical research organizations with performance and quality measurements, and analysis of real-world data. Read More
The Association of Clinical Research Professionals announced a new certification this past month, the Certified Professional program, open to all working in clinical studies. Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Trial master files should contain all documents necessary to adequately reconstruct the conduct of a clinical study, along with any decisions made and their justifications, according to European regulations. Read More
The European Medicines Agency published a draft proposal to accept measurements of fibrinogen as a biomarker to identify chronic obstructive pulmonary disease patients for inclusion in clinical trials. Read More
Scott Gottlieb was grilled by a Senate panel over his support for the FDA’s approval standards, as well as his willingness to stand up to his future boss, President Trump. Read More