Clinical Trial Monitoring is an essential element of the clinical trial process and a vital connection between the sponsor/CRO and the Research Site. Monitoring is the sponsor/CRO’s obligation to ensure that the Research Site conducts the trial per the protocol, SOPs, GCP, and any other regulatory requirements. Ultimately, when conducting an IND trial, regulations [...]
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Efficiently managing multicenter clinical trials is an essential capability of the modern research center. Complex protocols often require diverse subjects spread across a vast network of research sites - increasing pressure on the coordinating center to streamline operations, maintain oversight, and avoid compliance risks. While the challenges of managing multicenter trials is unique for [...]
Electronic Investigator Site Files (eISF) are now attracting the attention of progressive sponsors and CROs. Here, we’ll explore the different approaches and stages for connecting the site eISF directly to the sponsor Electronic Trial Master File (eTMF) and how this adjustment impacts the way clinical trials are conducted. Over the last five years, the [...]
Are you part of a multicenter clinical trial? If not, you may be soon. Multicenter trials, where a sponsor or CRO relies on a highly developed coordinating center to manage a network of sites, continue to gain popularity among sponsors looking to accelerate study timeline and reduce development costs. This growth is in direct [...]