When the same symptom is coded to different MedDRA terms in different studies, or by different coders, safety signals get split and aggregate reports become unreliable. Cloudbyz Safety & Pharmacovigilance codes adverse events with MedDRA and medications with WHODrug on one Salesforce-native platform, so coding conventions and dictionary versions are applied consistently across studies. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
Why coding consistency matters
- Regulatory submissions need it. Safety reports in ICH E2B(R3) format use MedDRA, and FDA has required E2B(R3) for IND safety reports since 1 April 2026 (FDA notice 2026-06660).
- Signals depend on it. If "liver injury" is coded three different ways across three studies, an aggregate review may miss a pattern. Under 21 CFR 312.32, aggregate findings can themselves require an IND safety report (21 CFR 312.32).
- Dictionaries change. MedDRA and WHODrug are both updated twice a year, so the version used for each term needs to be recorded and managed.
How it works today
- Each study, CRO or coder applies its own conventions.
- Coding happens in EDC for clinical data and again in the safety database for cases.
- Dictionary versions differ between systems and studies.
- Inconsistencies surface during DSUR preparation or pooled analysis.
Inconsistent versus consistent coding
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Area
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Scattered coding
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Cloudbyz Safety & PV
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Conventions
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Per study or coder
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Applied across studies
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Dictionary version
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Unclear per term
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Recorded with the coded term
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Version upgrades
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Handled separately in each system
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Managed on one platform
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Verbatim text
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Sometimes overwritten
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Kept alongside the code
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Aggregate review
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Signals split across terms
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Consistent terms across studies
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For large pharma and global multinationals
Large sponsors code thousands of terms across many studies, CROs and coding teams. What matters is one set of conventions applied everywhere, dictionary upgrades managed centrally, and a record of every coding decision, so pooled safety data holds together across the portfolio.
For biotechs and emerging sponsors
Biotechs often outsource coding to a CRO and inherit its conventions. When the programme moves to a second CRO or brings safety in-house, inconsistent coding becomes a problem. Keeping coding on the sponsor's own platform from the start avoids rework later.
How Cloudbyz Safety & PV does it
Cloudbyz Safety & Pharmacovigilance is built natively on Salesforce, with MedDRA and WHODrug coding as part of case processing, on the same platform as Cloudbyz EDC. Cloudbyz is also developing an AI Medical Coding agent, designed to suggest terms from the MedDRA dictionary itself rather than generating them, explain its reasoning, and save codes only when a coder confirms. Book a demo or visit cloudbyz.com.
