EDC is where trial activity is first recorded: every visit, procedure and adverse event. In most organisations that data is then exported to CTMS, safety and finance on a schedule. Cloudbyz EDC is built natively on Salesforce, on the same data model as Cloudbyz CTMS, Safety & Pharmacovigilance and CTFM, so a completed visit updates operations, an SAE is shared with the safety case, and earned amounts reach finance in real time. It is used by large pharma, global multinationals, biotechs, CROs and device companies.
Where EDC data needs to go
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Data in EDC
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Who needs it
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Why
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Subject visits and enrolment
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Clinical operations (CTMS)
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Site status, milestones, monitoring
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Serious adverse events
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Pharmacovigilance
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Expedited reporting within 7 or 15 days
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Completed visits and procedures
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Finance (CTFM)
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Site payments and accruals
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Queries and data status
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Data management and CRAs
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Cleaning and lock
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What a connected stack costs
- Delay. Exports and syncs mean each team works from data that is hours or days old.
- Re-entry. SAEs are often re-keyed into the safety database, and visits re-confirmed for finance.
- Reconciliation. Every copy needs checking against the source, before lock and at audit.
- Validation load. Every interface is another transfer to validate and monitor.
Why it matters for compliance
- Data governance. ICH E6(R3) expects data transfers to preserve data and metadata, and systems to be validated in proportion to risk (ICH E6(R3), EMA Step 5).
- Data originators. FDA's guidance on electronic source data expects the originator of each data element to be identified and an audit trail kept (FDA eSource guidance). Copies made by interfaces complicate that trail.
- Safety clocks. Under 21 CFR 312.32, IND safety report deadlines run from the sponsor's first receipt of the information, so delays between EDC and safety eat into the deadline.
For large pharma and global multinationals
Across a large portfolio, the number of EDC exports and interfaces grows with every study. A shared data model gives one consistent flow from EDC to operations, safety and finance for every study, reduces the validation work for each new study, and means accruals and safety oversight across the portfolio are built on the same source data.
For biotechs and emerging sponsors
Biotechs need EDC live quickly and can't afford integration projects. Starting with Cloudbyz EDC and adding CTMS, Safety or CTFM later on the same platform means data flows to each new module without building interfaces, and a small team has one source of truth from the first patient.
How Cloudbyz EDC does it
Cloudbyz EDC is built natively on Salesforce, with a form builder, eCRFs, edit checks and query management. Because it shares a data model with Cloudbyz CTMS, Safety & PV, CTFM and eSource, completed visits update CTMS and create earned amounts and accruals in CTFM, SAEs can be shared with the safety case, and data captured once in eSource doesn't need to be re-entered. Book a demo or visit cloudbyz.com.
