Continuous, not periodic
Loopa reconciles against the live protocol the moment data is entered. Amendments and clarification letters update the rules in flight. Deviations surface within minutes, not weeks later at the next monitoring visit.
Loopa continuously reconciles source, eSource, and EDC against the protocol, so deviations surface in real time, not at the next monitoring visit.
Source data verification happens at monitoring visits, often weeks after the data was entered. A missed inclusion criterion, an out-of-window assessment, or an unreconciled value can sit undetected until a monitor, or an auditor, finds it. By then the deviation is history, not a heads-up.
Loopa reads every source document and cross-references it against the protocol and the EDC the moment it lands. The work that consumes a monitor's day runs automatically and constantly, so your team spends its time resolving issues instead of hunting for them.
Continuous QA that fits inside your existing workflow, no rip and replace, no new EDC.
Loopa ingests paper packets, eSource forms, EMR exports, and scans, structuring every field at intake. ALCOA+ from the first upload.
Visit windows, eligibility, eCRF entries, and lab values reconcile against the live protocol, amendments and clarification letters included. PI and delegated signatures reconcile against the DoA log. Continuous, not a Friday-night batch job.
When a value falls outside protocol, the deviation surfaces immediately with the field, the source, the protocol citation, and a suggested query. Not at the next monitoring visit.
Export inspection packets, deviation logs, CAPA records, and source-to-EDC reconciliation reports in formats that satisfy FDA BIMO and EMA. No scramble before a visit.
Sites face the monitor. CROs face the sponsor. Sponsors face the FDA. Loopa runs one protocol-bound reconciliation across all three. Same record, same trail, three different defenses.
Catch visit window misses within minutes of source upload, not weeks at the next monitoring visit.
Paper, eSource, and EMR exports land ALCOA+-structured at intake. Eligibility, lab ranges, and PI signature-vs-DoA reconcile against the live protocol. Every field, every visit.
Risk-based monitoring on field-level reconciliation. Not visit-cadence sampling.
The continuous, exception-driven approach ICH-GCP E6(R3) calls for. One protocol-bound rule layer across every site. SDV by exception, not by sample.
Submission-ready evidence at database lock. Not six months later.
ALCOA+ enforced at field level. 21 CFR Part 11 audit trail per record. BIMO packets on demand, per protocol section, per visit, per finding.
CLARA is the assistant built into Loopa. It's grounded in your protocol, source documents, and EDC, so every answer traces back to the record it came from. No hunting through binders, no guesswork.
From the first source document to the final submission, nothing falls out of frame.
Loopa reconciles against the live protocol the moment data is entered. Amendments and clarification letters update the rules in flight. Deviations surface within minutes, not weeks later at the next monitoring visit.
Field-level reconciliation across every visit, every subject, every document. No critical-field-only sampling. No representative slice.
Every finding ships with its protocol citation, source location, field-level diff, and suggested query. Not a backlog of context-free flags to triage.
21 CFR Part 11 audit trail builds with every field touched. Deviation logs, CAPA records, and reconciliation reports stay BIMO-ready throughout, not assembled in the months before inspection.
See how Loopa reconciles your source, eSource, and EDC against the protocol in real time. We'll walk your team through a study of your choosing.
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