Best Practices – Leveraging the Biostatistician

We continually urge our Sponsor/CRO clients to make better use of their study Biostatistician. These professionals have more to contribute than most realize. Yes, they crunch the numbers and help with the final study submission – but they have more to offer than that....

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...

Announcing Enhancements to VISION™ Reports!

Prelude Dynamics, LLC, has released some exciting new enhancements to the VISION™ Reports tool. This function of their Electronic Data Capture (EDC) system allows users to view data according to the criteria of their choosing at any point in the study. Reports can be...

New EDC Feature for POC and Phase 1 studies

Prelude announces a new EDC feature that streamlines data entry for Proof of Concept (POC) or Phase 1 studies. Multiple Subject Data Entry allows users to enter data for multiple subjects at the same time using a single form. Users can configure this form at the site...

Best Practices for Remote Clinical Monitoring 

What does it mean to conduct effective remote clinical monitoring? It’s critical to be using an EDC in order to accomplish this, but what else is necessary? Keeping the primary goals of the monitor in mind, we will outline several techniques for streamlining this...

New Reality of Remote Audits

This morning, Prelude attended a meeting on the new reality of remote audits and inspections. In the past, remote auditing of sites was viewed as a nice capability. As many in the industry are now learning, remote capabilities are now a necessity.