Perspectives on clinical systems governance and data integrity
Lauren Alani writes about the ecosystem view of clinical trial data, the structural patterns that determine whether sponsor accountability holds under inspection, and the regulatory shift sponsors are navigating.
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Data integrity is a commercial risk, not regulatory paperwork.
Inspectors and partnership diligence teams read the same evidence and ask different questions of it. Treating data integrity as enterprise risk produces records that work for both audiences.
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Requirements before selection. Why the procurement sequence matters more than the platform.
Selecting clinical technology before defining trial-level requirements is a procurement risk. Vendor demos optimise for the vendor’s strengths; trial fitness has to be evidenced in the sponsor’s own…
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The regulator-vendor gap is structural. Sponsors absorb it by default.
Regulators write to sponsors. Vendors operate one layer down, accountable to sponsors but not directly to regulators. The structural gap is real, persistent, and the sponsor’s job to…
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Accountability cannot be delegated. The sponsor signed the protocol.
Master service agreements transfer the work, not the regulatory accountability. ICH GCP E6(R3) and the inspector’s ledger both ask the sponsor, regardless of who built the system or…