Trusted Resource for Clinical Trials, Protocols & Progress
The start-up phase encompasses all activities from site selection to site activation, ending when a site is ready to enroll subjects. This process includes feasibility assessments, regulatory submissions, contract negotiations, and site initiation visits (SIVs).
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Virtual feasibility evaluations were initially accelerated by the COVID-19 pandemic, but their benefits have extended far beyond travel restrictions. Sponsors and CROs are increasingly relying on remote solutions to:
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Clinical trial regulations set the foundation for ethical conduct, subject protection, and data integrity. Regulatory oversight agencies—such as the USFDA, EMA, and CDSCO—require documented evidence that investigational sites are capable of meeting regulatory standards before approval.
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The Case Report Form (CRF) is a clinical document used to collect data from each trial participant according to the protocol. In modern trials, electronic CRFs (eCRFs) are used within Electronic Data Capture (EDC) systems.
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Clinical trial regulations set the foundation for ethical conduct, subject protection, and data integrity. Regulatory oversight agencies—such as the USFDA, EMA, and CDSCO—require documented evidence that investigational sites are capable of meeting regulatory standards before approval.
Click to read the full article.
Site success is driven not just by infrastructure or patient availability but also by the people running the study. Inadequate staff time allocation can lead to:
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Site success is driven not just by infrastructure or patient availability but also by the people running the study. Inadequate staff time allocation can lead to:
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Query resolution time refers to the duration between the issuance of a data query by the data management team or clinical monitor and the time it takes for the site to respond and close that query. It is a reflection of the site’s responsiveness, familiarity with the protocol, and data management capabilities.
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A site’s ability to manage study procedures, patient safety, and data integrity depends heavily on its infrastructure. Failure to verify the presence and functionality of essential equipment during feasibility can result in:
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A site’s ability to manage study procedures, patient safety, and data integrity depends heavily on its infrastructure. Failure to verify the presence and functionality of essential equipment during feasibility can result in:
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