by Patricio Ledesma | Jan 30, 2022 | Quality
Contact info@sofpromed.com to learn more about how to prepare for an FDA clinical site inspection You are a hospital or clinic participating in a clinical trial and one day two officers from the US Food and Drug Administration (FDA) arrive at your facility...
by Patricio Ledesma | Feb 27, 2019 | Quality
According to ICH-GCP, section 5.19.1: “The purpose of an audit, which is independent of and separate from routine monitoring and quality control functions, should be to evaluate trial conduct and compliance with the protocol, Standard Operating Procedures (SOP), Good...
by Patricio Ledesma | Feb 4, 2019 | Quality
The term “quality”, when talking about clinical trials, is related to various elements and concepts. But what are the basics of quality that any clinical trial should meet? On what grounds is quality based when we talk about drug-related clinical trials?...