Get Ready for FDA E2B(R3):
What PV Teams Need to Know
This edition of Veeva’s Safety Newsletter spotlights the FDA E2B(R3) reporting requirement for serious and unexpected suspected adverse reactions (SUSARs) and what PV teams need to do to prepare for the upcoming deadline.
Tuesday, August 5, 2025
By Christina Kim and Celine Ghafari
scPharmaceuticals: When to Bring Medical Information Systems In-House
The turning point for scPharmaceuticals and advice for others making the same decision.
Monday, August 4, 2025
By Allie Reynolds
Thoughts on Veeva Vault CRM Versus
Salesforce CRM for Biopharma
Facts and information to help companies evaluating Veeva Vault CRM versus Salesforce CRM for biopharma and biotech.
Monday, July 28, 2025
By Peter Gassner
Simplify Planning to Publishing with Unified Submission Content Plans
Moving from fragmented to unified SCP data and processes on an end-to-end RIM platform, regulatory teams can simplify submission management, maintain compliance, and drive operational efficiency.
Friday, July 25, 2025
By Alison Marjanowski
Driving RIM Excellence and Innovation Through a Data-Centric Approach
To keep pace with evolving health authority (HA) standards, organizations are taking a data-centric approach with unified RIM systems to improve regulatory efficiency and agility.
Wednesday, July 23, 2025
By Paul Attridge
The Case for Early Data Management Input in eCOA
Discover how earlier involvement from data managers can transform eCOA data capture and management, paving the way for better upfront decisions and smoother processes.
Friday, July 11, 2025
By Michelle Marlborough
Modernizing LIMS with Embedded
Test Method Execution
Modern LIMS solutions bridge the gap between lab management and lab execution, breaking away from legacy standards and paving the way for QC optimization.
Friday, July 11, 2025
By Justin Lavimodiere
Clinical Transformation:
Results From Biopharma and CRO Leaders
Discover how leading biopharma companies are overcoming clinical trial challenges with connected systems, featuring key successes and advice from the Veeva EU R&D & Quality Summit.
Friday, July 11, 2025
By François Caijo
Reduce Reconciliation of Clinical
Serious Adverse Events (SAE)
This month’s edition of Veeva’s Safety Newsletter spotlights the Safety-EDC Connection and how it automates the flow of serious adverse event (SAEs) records from data management teams to the safety inbox and reduces reconciliation.
Wednesday, July 9, 2025
By Christina Kim and Celine Ghafari
Automate Safety Letter Distribution: 80% Faster and 50% Less Effort
This month’s edition of Veeva’s Safety Newsletter spotlights safety letter distribution. See how to automate delivery of critical safety information to investigators and regulators with speed, efficiency, and quality.
Wednesday, July 9, 2025
By Christina Kim and Celine Ghafari