Donatella Ballerini

Sep 27, 2024 | clinicalleader.com | Donatella Ballerini |Jessica Scott |Jennifer Millman

Webinar: From Crisis to Confidence in Medical WritingThe regulatory submission process is complex and filled with challenges that can jeopardize critical filings. In this session, we’ll explore the key obstacles medical writing submission specialists face today and share proven strategies to ensure successful submissions every time. Click here to learn more.

Sep 19, 2024 | clinicalleader.com | Donatella Ballerini

By Donatella Ballerini, GCP consultant In the complex world of clinical research, GCP stands as a critical framework ensuring trial participants' safety and data integrity. While GCP’s role in the operational conduct of clinical trials is well recognized, its impact during site feasibility is equally vital yet often under-discussed. This article explores how adherence to GCP influences these early and crucial stages of clinical trials, shaping their success and credibility.