Automate Safety Letter Distribution: 80% Faster and 50% Less Effort

Jul 08, 2025 | Christina Kim and Celine Ghafari

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.

Ensuring timely safety letter distribution to all sites

From the initial report of a suspected unexpected serious adverse reaction (SUSAR) to notifying sites, patient safety data can change hands 10 or more times across multiple systems and organizations.

Generating and distributing safety letters relies heavily on accurate and transparent data as well as:

• Alignment on core study data with sites and clinical teams
• Accurate, complete, and timely data transfer of SUSARs
• Seamless case intake and safety letter generation
• Compliant letter distribution and acknowledgement

With siloed systems, it is challenging to support timely processing and reporting of adverse events without impacting data quality. Additionally, there is a significant data reconciliation burden for all stakeholders to ensure data consistency. The full list of sites can often change, making it difficult to ensure they all receive and acknowledge relevant safety letters.

“From a regulatory perspective, it’s imperative that you distribute your cases to the right people, that you ensure that they get your cases, and that you can prove that they got them.” — Former Chief Operating Officer, Biotech

Seamless data transfer with end-to-end automation

End-to-end automation significantly reduces manual data entry, provides timely information to stakeholders, and links data back to the source, resulting in:

• Less burden on sites
• Improved data integrity
• Reduced reconciliation
• Better safety compliance

Safety teams can automatically generate and distribute safety letters to all sites, using the relevant site list in the clinical system, as well as track acknowledgements. Seamless data flow between clinical and safety systems ensure complete and timely delivery of safety information to sites.

Automate End-to-end Clinical Patient Safety for Improved Efficiency and Data Quality

26 minutes
Hear Veeva safety experts discuss how end-to-end automation can accelerate delivery of safety letters by 80% faster while reducing effort by 50%.

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