User Acceptance Testing (UAT) is a critical component of clinical trial development using Electronic Data Capture (EDC). It’s the responsibility of the Sponsor/CRO to perform UAT prior to using the EDC to collect data in accordance with a protocol. Early and thorough...
Did you know that each VISION™ study comes with a set of standard Summaries? They aggregate Subject and Site-level data, enabling faster monitoring and data validation. Standard Subject-level summaries may include Subject Status, Form Status, Query Details, and...
Currently FDA official submissions must be in XML or PDF format, with the preference being the submission of at least the XML format. The rationale for these is the need to have a document that will be readable and accessible in perpetuity. This is definitely an...
Challenge It is challenging for working clinics to ensure sufficient inventory of treatment and control medications or supplies are available throughout a clinical study. Prelude Dynamics was challenged to identify an inventory management system that was...
AUSTIN, TX – March 10, 2016 – Prelude announced today that it has enhanced its feedback tool. Clients use VISION’s feedback tool during the study build process to communicate changes and needs to their Prelude Project Manager. Feedback is integrated...
Challenge When multiple raters will be used to assess the condition of a subject, it is important to improve inter-rater reliability, particularly if the raters are transglobal. The complexity of language barriers, nationality custom bias, and global...
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