Trials run inside your own institution.
How ZINOS fits FDA trial rules, IRB review, and 21 CFR Part 11, with records kept inside your institution.
Trial approval in the United States.
A drug trial may begin 30 days after FDA receives the IND, once an IRB has approved it.Source21 CFR 312.40(b), ecfr.gov21 CFR 56.103(a)
- IND or IDESource21 CFR 312.40(b), ecfr.gov21 CFR 812.42 and 812.30(a)
- FDA, 30 daysSource21 CFR 312.40(b), ecfr.gov21 CFR 812.42 and 812.30(a)
- IRB approvalSource21 CFR 56.103(a)
- ClinicalTrials.gov within 21 daysSource42 CFR 11.24(a)
- Trial conduct
- Records kept two yearsSource21 CFR 312.62(c); 21 CFR 812.140(d)
US rules, and how ZINOS fits.
- 21 CFR Part 11 audit trails: time-stamped, attributed, never overwrittenSource21 CFR 11.10(a), 11.10(e), 11.50
- Part 11 signatures show signer, date, time, and meaning: built inSource21 CFR 11.10(a), 11.10(e), 11.50
- Single IRB for Common Rule cooperative research: approvals tracked per siteSourcehhs.gov
- Research use of health information follows HIPAA; records stay insideSourceHHS, HIPAA for Professionals, Research, hhs.gov
- ICH E6(R3), final FDA guidance in 2025: the site holds its recordsSourceFederal Register 2025-17311
Where the record sits in the US.
With on-premise deployment, FDA, the IRB, and sponsors receive what the rules require, and records stay inside your institution.Source21 CFR 56.103(a)
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- IRB
- FDA
- Sponsor
- Monitor
US requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| IRB approval before start | 21 CFR 56.103Source21 CFR 56.103(a) | Approval tracking in the site file |
| Audit trails on electronic records | 21 CFR 11.10(e)Source21 CFR 11.10(a), 11.10(e), 11.50 | Every change logged, time-stamped, attributed |
| Electronic signatures | 21 CFR 11.50Source21 CFR 11.10(a), 11.10(e), 11.50 | Signer, date, time, and meaning recorded |
| Investigator record retention | 21 CFR 312.62(c) and 812.140(d)Source21 CFR 312.62(c); 21 CFR 812.140(d) | Configurable retention and archival |
| Electronic informed consent | FDA and OHRP guidance, 2016SourceHHS OHRP, Use of Electronic Informed Consent: Questions and Answers | Tablet eICF with audit trail |
| Research use of health information | HIPAA Privacy RuleSourceHHS, HIPAA for Professionals, Research, hhs.gov | Institution-controlled deployment |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against US rules.
Book a call on running trials in the United States, and bring your DPO.