Quality by Design – It’s not an Accident!

Incorporating Quality By Design in EDC-based Clinical Trials Quality by Design (QbD) defines quality as freedom from errors that matter. In the context of an EDC-based clinical trial, this could mean interruptions in study conduct, issues with data integrity, concerns...

Visit us at the 2022 Annual SQA Meeting!

Prelude Dynamics is proud to announce our participation in the 2022 Annual SQA Meeting. You can connect with us at this event in two ways. Attend this informative presentation by Ann-Marie Kiser (Director, Quality Assurance) and Alex Peters (Project Manager). What: ...

Why Sites Prefer VISION™ – Part 1 – Integrated Audit Trail

We consistently get feedback from our clients that their sites prefer working with VISION™. When sites know they will be using a preferred EDC, they are more likely to participate in a study, are better at meeting enrollment objectives, and are more likely to adhere...

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...