Prelude Dynamics’ VISION™ platform is the only EDC that provides an electronic interface with IDEXX labs – making VISION the preferred EDC in animal health. This interface greatly reduces the errors inherent in manual reporting, which saves clinicians and pet owners...
Source Data Verification Prelude Dynamics continues to enhance our VISION™ platform with crucial features requested by our clinical trial user community. The ability to perform Source Data Verification (SDV) in the context of EDC has become more and more important...
The importance of testing all aspects and features of a study before Go-Live cannot be over-emphasized. That being said, testing can be a very messy process. If not undertaken with a great deal of planning and documentation, the whole process of testing a study can be...
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...
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...
There are plenty of reasons it might be necessary to make a change to an Electronic Data Capture system after data collection has begun for a study. These range from simple to complex and may stem from a protocol amendment. Some examples include…
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