eCOA & IRT · clinical trial systems validation
Validation discipline for regulated trial environments.
iSinghLabs brings 21 CFR Part 11 and HIPAA validation rigor to electronic clinical outcomes assessment and interactive response technology: air-gapped data handling, an audit trail on every output, and a scope locked to the clinical domain, delivered at SMB and mid-market scale.
Built for evidence, not for demos.
Clinical outcomes data carries regulatory weight the moment it is captured. Every part of this practice is built around proving that weight was handled correctly, not just handled.
21 CFR Part 11 and HIPAA discipline
Validation practice built to the standard regulated trial sponsors and sites already answer to, applied to how AI touches clinical outcomes data.
Air-gapped, no-egress handling
Regulated clinical data is processed on infrastructure with no path to the open internet during a job, not merely a policy promise.
Audit trail on every output
Findings are grounded in cited source material, not a black-box judgment, so every conclusion can be traced back to what produced it.
Scope locked to the clinical domain
Each engagement runs against a template and configuration built for that study, never a general-purpose model asked to guess at clinical context.
Independent verification for IRT, before the first patient is randomized.
Interactive Response Technology (IRT, also called IWRS or RTSM) decides which arm a patient is assigned to and which kit ships where. A configuration error there becomes a protocol deviation in production. iSinghLabs verifies the system the vendor built, independent of that vendor, so the sponsor signs off on evidence rather than on a demo.
Configuration review against the requirement register
Every setting in the vendor's configuration workbook is checked against the user requirements and the specification, line by line. Each discrepancy is listed with the requirement it fails.
UAT scripts with a traceability matrix
Requirements become executable test scripts, and the matrix shows which requirement each script covers. Coverage is measured, not asserted.
Mock randomization verification
The dummy randomization run is checked against the schedule, the stratification rules, and the kit assignments before go-live. An allocation error is caught in the mock, not in a patient.
Vendor-agnostic, with a human sign-off
The work fits whichever IRT vendor the sponsor already uses. The evidence pack supports the release decision; a qualified person makes it, never a tool on its own.
A conversation first, then a scoped engagement.
Every engagement starts with a discovery call to understand your trial environment, your existing eCOA and IRT tooling, and the regulatory scope that applies to you. From there, the work is scoped to what your study actually needs, with the same Fortune 1-100 quality-engineering rigor iSinghLabs brings to every practice.
Bring evidence to your next audit, not a promise.
A 30-minute call is the fastest way to see how eCOA and IRT validation fits your trial environment.