Cloudbyz Safety & PV: Signal Management and Aggregate Review for Clinical Trials

Single-case reporting is only half of pharmacovigilance. Sponsors also need to look across cases for patterns, such as an event happening more often in the treatment group, and act on them. Cloudbyz Safety & Pharmacovigilance, a Salesforce-native safety system, includes statistical signal management alongside case processing, so aggregate review works from the same coded, current case data. It is used by large pharma, global multinationals, biotechs, CROs and device companies.

Why aggregate review matters now

• It can trigger an IND safety report. Under 21 CFR 312.32(c)(1)(i)(C), findings from an aggregate analysis showing an event occurs more often in the drug group than in a control group can require an expedited IND safety report (21 CFR 312.32).
• FDA has raised the bar. FDA's December 2025 final guidance on sponsor safety reporting puts more emphasis on aggregate analysis and a documented safety surveillance plan (RAPS; FDA guidance).
• Annual reports depend on it. DSURs and EU annual safety reports summarise the safety profile across the reporting period.

How it works today

• Line listings are exported from the safety database every quarter.
• Analysts build pivot tables in spreadsheets to look for patterns.
• Signal decisions are recorded in meeting minutes or emails.
• Nobody can easily show why a pattern was, or wasn't, escalated.

Spreadsheets versus Cloudbyz Safety & PV

For large pharma and global multinationals

Large sponsors review signals across many studies, indications and sometimes marketed products at once. What matters is consistent coding across all of them, a documented process for every signal decision, and aggregate review that can draw on cases from every CRO and region, not only those in one study's listing.

For biotechs and emerging sponsors

For a biotech, the first formal aggregate review often comes with the first DSUR, and FDA now expects a safety surveillance plan from the start. What matters is a simple, documented process the small team can actually run, on data it controls, even when case processing is outsourced.

How Cloudbyz Safety & PV does it

Cloudbyz Safety & Pharmacovigilance is built natively on Salesforce, on the same platform as Cloudbyz EDC. According to Cloudbyz product materials, it supports multi-source case intake including E2B R2 and R3, MedDRA and WHODrug coding, automated labelling and narratives, a submission gateway for E2B and MedWatch, and statistical signal management. Book a demo or visit cloudbyz.com.