Bring Safety In-house for Better Oversight, Simplified Operational Reporting, and CRO Flexibility

May 14, 2025 | Christina Kim and Celine Ghafari

This edition of Veeva’s Safety Newsletter shares how to achieve greater CRO collaboration and better pharmacovigilance (PV) oversight with easier operational reporting.

Efficient PV Operations with Hybrid Outsourcing Model

Managing safety vendors with limited resources and evolving regulations is challenging for emerging or small biotechs. Research shows 49% of biotech companies outsource to at least three vendors, and 11% outsource to five or more.

Growing scrutiny from regulators on outsourcing processes, data integrity, and adequate oversight to ensure safety reporting and monitoring remain high-quality and compliant is increasing the workload for PV teams.

Bringing Safety In-house to Overcome Outsourcing Challenges

Pharmacovigilance (PV) teams gain greater control and have direct oversight and outsourcing flexibility by bringing a safety system in-house. They can continue to leverage vendors for case processing and other PV activities, while experiencing many other benefits including:

• Improved data quality and safety outputs: Real-time reports and dashboards tracking case processing time, case quality, and regulatory reporting compliance.
• BPO flexibility: Change CROs or work with multiple vendors without disrupting safety operations, as safety data is owned and controlled by the sponsor.
• Accelerated case processing: One end-to-end global case processing solution from intake to submissions with rule-based or manual case distribution.
• Streamlined and automated processes: Seamlessly connect Veeva Safety to Veeva EDC, Veeva eTMF, Veeva RIM, and Veeva MedInquiry to automate AE intake and other safety processes and synchronize information such as product and study data.
• Easily scale safety: From a study to commercialization, mitigate compliance risks and have confidence in your trial data.

Real-Time Oversight and Operational Efficiency with In-house Safety Solution

5 minutes
See how CROs can collaborate in a sponsor’s safety system to create dashboards and operational reports for better data insights. Explore how Veeva Safety centralizes safety data and automates case processing.

Bring Safety System In-house: Direct Oversight and Control While Gaining CRO Flexibility

2 minutes
Hear how Inhibrx brought a safety system in-house for direct oversight and control while gaining CRO flexibility.

“We wanted to have our own global safety database so that we could see data in real-time, but still be able to partner with CROs because we are a small company” – Bonne Adams, Vice President Operations, Inhibrx Biosciences, Inc.

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