VISION™ Tips & Tricks: Utilizing Summaries

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...

A Case for HTML Archives for FDA Submission

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...

Inventory Management & Automatic Reordering

  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 smart...

Improving Inter-Rater Reliability

  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 locations...

Randomization

Challenge Ensuring that patients are appropriately randomized to the correct treatment group is a critical factor for all clinical studies. Additionally, it is imperative that designated study personnel are masked to the assigned treatment group unless there is a...
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