The Development Safety Update Report (DSUR) and the EU and UK annual safety reports summarise the safety of an investigational product across all its trials for the year. Preparing them means pulling cases, line listings, cumulative tables and signal decisions together by a fixed date. Cloudbyz Safety & Pharmacovigilance holds that data on one Salesforce-native platform, coded and current, with Cloudbyz EDC on the same platform for the underlying trial data. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
What the rules require
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Report
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Region
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Key points
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DSUR (ICH E2F)
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ICH regions
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Annual report on the investigational product, generally due within 60 days of the data lock point
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IND annual report
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US
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Within 60 days of the IND anniversary (21 CFR 312.33); FDA accepts a DSUR in its place
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Annual safety report
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EU
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Submitted for each investigational medicinal product under the Clinical Trials Regulation (Regulation (EU) 536/2014, Chapter VII)
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Annual safety report
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UK
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Submitted only to the MHRA since 28 April 2026 (HRA)
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Late or incomplete annual safety reports are inspection findings, and gaps in the underlying data make them hard to defend.
How it works today
- Cases are exported from the safety database, and trial data from EDC.
- Line listings and cumulative tables are built in spreadsheets.
- Signal decisions are pulled from meeting minutes.
- Coding differences between studies are fixed under deadline pressure.
What a single source changes
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Need
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Scattered data
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Cloudbyz Safety & PV
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All cases for the period
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Exports from several systems
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Cases on one platform
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Consistent coding
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Fixed at report time
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MedDRA and WHODrug coding throughout
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Signal decisions
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Minutes and emails
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Recorded with signal management
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Trial exposure context
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Separate EDC export
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Cloudbyz EDC on the same platform
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Audit trail
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Hard to show
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Kept on the platform
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For large pharma and global multinationals
Large sponsors prepare DSURs for many products, each drawing on several trials, CROs and regions, often with different reporting calendars. What matters is one consistent case set and coding across all of them, so each report is assembled rather than reconstructed.
For biotechs and emerging sponsors
A biotech's first DSUR often arrives a year into its first IND, with a small team and data spread across a CRO and an EDC vendor. What matters is having its own complete, coded case data, so the first report is accurate and the next one is easier.
How Cloudbyz Safety & PV supports it
Cloudbyz Safety & Pharmacovigilance is built natively on Salesforce. According to Cloudbyz product materials, it supports multi-source case intake including E2B R2 and R3, MedDRA and WHODrug coding, automated narratives and statistical signal management, giving annual reports a single, current data source. Book a demo or visit cloudbyz.com.
