Best Practices for eClinical Mid-Study Updates

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: Modifications to eCRF...

Best Practices for Managing Site Invoicing in Clinical Studies

Sponsors and CROs invest a lot of time and money in recruiting sites for clinical trial conduct. Sites whose personnel are familiar with EDC and GCP, and who have demonstrated their ability to accurately follow protocol procedures are incredibly valuable resources....

Best Practices for eCRF Design – Part 2

Let’s continue exploring the art of eCRF design with a discussion of additional best practices! In Part 1 we discussed: Emulate paper forms. “Right-size” each form (not too little or too much data) Consider the site’s workflow Consider masking implications Group...

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...

Key Considerations when Running a Cross-Species Comparative Trial

Did you know 90% of investigational products don’t make it to approval? Why? Because of poor efficacy.  One way to mitigate the risk of failure before investing too much is to perform cross-species comparative studies, an emerging approach in clinical research....

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...