Many sponsors outsource safety case processing to a CRO, but the sponsor remains responsible for reporting on time and for the safety of participants. Oversight that relies on monthly CRO reports leaves the sponsor a month behind. Cloudbyz Safety & Pharmacovigilance can give sponsors their own Salesforce-native safety platform, with case status, reporting clocks, submissions and coding visible at any time, whoever processes the cases. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
Why sponsors stay responsible
- GCP. Under ICH E6(R3), a sponsor can transfer trial activities to a service provider, but ultimate responsibility stays with the sponsor, and it should have access to the information it needs for oversight (ICH E6(R3), EMA Step 5).
- US rules. Any transfer of sponsor obligations to a CRO must be described in writing (21 CFR 312.52), and IND safety report deadlines remain the sponsor's (21 CFR 312.32).
- FDA's 2025 guidance. FDA's December 2025 sponsor safety reporting guidance sets out the sponsor's responsibilities for safety assessment, including aggregate analysis (FDA guidance).
What sponsors need to see
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Oversight question
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Monthly CRO report
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Sponsor's own platform
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Which cases are open, and how close to deadline?
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As of last month
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At any time
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Were expedited reports submitted on time?
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Summary table
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Each submission and acknowledgment
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Is coding consistent?
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Not visible
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Coded terms and versions
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Are there emerging signals?
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CRO's view
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Sponsor's own aggregate review
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Can we change CRO without losing history?
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Data migration project
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Cases stay on the sponsor's platform
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For large pharma and global multinationals
Large sponsors often use several CROs and safety vendors across regions. What matters is one safety platform that all of them work in, or report into, so the sponsor sees every case on the same terms, applies the same coding and has a single audit trail across vendors.
For biotechs and emerging sponsors
Most biotechs outsource case processing early. What matters is keeping control of their own safety data from the first IND, so oversight is real, inspection questions can be answered directly, and switching or bringing PV in-house later doesn't mean losing history.
How Cloudbyz Safety & PV supports oversight
Cloudbyz Safety & Pharmacovigilance is built natively on Salesforce, with role-based access that can let CRO case processors work in the sponsor's system while the sponsor sees everything. Book a demo or visit cloudbyz.com.
