SAE reconciliation exists because the same serious adverse event is recorded twice: once in EDC by the site and once in the safety database by pharmacovigilance. Data managers and safety teams then compare listings, chase differences and repeat before every lock. With Cloudbyz EDC and Cloudbyz Safety & Pharmacovigilance on one Salesforce-native platform, an SAE entered in EDC can be shared with the safety case, so there is one record to keep in step instead of two to reconcile. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
How it works today
- The site records the SAE in EDC and sends an SAE form.
- Safety staff re-enter the event in the safety database.
- Follow-up information is updated in one system and not the other.
- Every month, and before lock, listings from both are compared.
- Differences in onset date, term, seriousness, causality or outcome are queried and resolved by hand.
Why it matters
- Reporting clocks. Investigators report SAEs to the sponsor immediately under 21 CFR 312.64(b), or within 24 hours in the EU. Sponsors then have 7 or 15 days for expedited reports, starting from first receipt (21 CFR 312.32; Regulation (EU) 536/2014, Chapter VII). Re-entry delays eat into that time.
- E2B(R3). FDA has required IND safety reports in E2B(R3) since 1 April 2026 (FDA notice 2026-06660), so case data needs to be complete and consistent.
- Inspection findings. EDC and safety data that disagree raise questions about which record is right, and slow database lock.
Two records versus one
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Step
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Two systems
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Cloudbyz EDC and Safety on one platform
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SAE recorded
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In EDC, then re-entered
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In EDC, shared with the safety case
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Day zero
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Depends on when re-entry happens
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Visible from the EDC record
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Follow-up
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Updated twice
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Updated on one record
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Monthly reconciliation
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Listing comparison
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Little left to compare
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Before lock
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Reconciliation sprint
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Confirm rather than reconcile
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For large pharma and global multinationals
With many studies, CROs and safety vendors, SAE reconciliation becomes a standing workload across the portfolio, often split across organisations. One shared record per event reduces that workload, gives pharmacovigilance the same data the sites entered, and supports consistent aggregate review across studies.
For biotechs and emerging sponsors
Biotechs often outsource safety to a CRO while running EDC elsewhere, so reconciliation crosses company boundaries. Keeping EDC and safety on one platform, even when a CRO processes the cases, gives the sponsor its own view of every SAE and removes a reconciliation step that small teams struggle to staff.
How Cloudbyz does it
Cloudbyz EDC and Cloudbyz Safety & Pharmacovigilance are built natively on Salesforce. SAEs entered in EDC can be shared with the safety case, where they are coded with MedDRA, assessed and submitted in E2B(R3), with a full audit trail across both. Book a demo or visit cloudbyz.com.
