Best Practices for eCRF Design – Part 1

We all know that eCRF design is more of an art than a science. That being said… there are still some general rules that should be followed when designing eCRFs. Keeping these in mind when designing forms will make them easier to use for site personnel, monitors and...

Virtually Visit Us at SQA’s 2021 Annual Meeting

Learn how you can enhance patient compliance via Electronic Patient Reported Outcomes (ePRO). Our Director of Quality Assurance, Ann-Marie Kiser, will be giving a virtual presentation on April 13th at the 2021 Society of Quality Assurance Annual Meeting. With the ePRO...

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...