Field-by-Field Audit Trail – Adopt Early or Not?

So, how does it work? And how is it different from the standard form-based audit trail? Typically, the audit trail is updated using the date/time that the form was saved as the entry/modification time for each field on the form. With field-by-field, the audit trail is...

How to Design an Auditor Friendly Clinical Study

Knock, Knock! The BIMO (or FDA QSR) auditor is at the door. It’s time to race around, retrieve documents from file cabinets, and make them easily digestible. Or is it? If your study is designed with audits in mind, you can relax instead of panicking. But how? One of...

Introducing the VISION SOP Manager

Why use two different systems to manage clinical data and SOPs? Organizations who use VISION™ will be interested to know that Prelude Dynamics offers an out-of-the-box SOP Management tool.  This flexible tool is implemented using VISION and supports all the familiar...

What is the Purpose of User Acceptance Testing?

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...

Six Ways an Electronic Data Capture System Saves Time

An EDC improves efficiency and reliability while conducting clinical research. Here are some ways it does that: 1. Efficient Communication The efficiency of communication between team members is what determines the success or failure of a clinical trial. If a team...

Prelude Returns to Speak & Exhibit at 2019 SQA Annual Conference

Prelude Dynamics is thrilled to be returning as the premiere EDC exhibitor at this year’s 2019 Annual Society of Quality Assurance Conference in Atlanta. We are excited to exhibit and engage with SQA members on the increasing demands of electronic data capture in...