Signed documents
Every signature carries its signer and timestamp.
Every trial you run, on one system.
Site file, eCRF, visits, consent, payments, and monitoring, on your own servers.
- Validation-ready
- Built to Part 11 and Annex 11
- Hospital-built since 2012
Where trial units lose their time.
A busy trial unit works across sponsor portals, paper binders, and spreadsheets, and types the same patient data again and again.
- Site files on paper, checked by hand before each monitoring visit
- Visits tracked in spreadsheets only one person understands
- Consent signed on paper and filed days later
- Patient payments chased by email
- A separate login for every tool
Sponsor systems your protocols require stay. Paper goes when your hospital decides.
What ZINOS is, and what it changes.
ZINOS is a clinical site operating system: software installed in your hospital that manages every clinical trial you take on, from feasibility to archive.
Your team stops copying data between systems and chasing paper, and every trial record stays in your hospital.
One system, one login
Site file, eCRF, visits, consent, and payments, all in one place.
Data entered once
Enter a lab result once and it fills the eCRF and the site file.
Audit trail built in
Every signature, version, and change is logged automatically.
Your data stays with you
Runs on your servers. Sponsors and monitors see only what you share.
From feasibility to archive, one system.
- Feasibility
- Capacity planning
- Start-up
- Site file set-up
- Study built from protocolIn development
- Enrolment
- Electronic consent
- Local pre-screeningIn pilot
- Visits
- Visit calendar
- Patient compensation
- Monitoring
- Remote source verification
- Close-out and archive
- Retention policies
A coordinator's day in ZINOS.
A study coordinator's Monday, step by step.
SiteStudiesDocumentsData HubFinance
JN
Site / overview
Site overview
Mon 28 Sep 2026
StudyAll studies
3Visits today
14Visits, next 7 days
47Email documents to fileNeeds filing
18Awaiting signatureNeeds signature
26Expired or expiring within 30 daysInspection risk
9Missing from the eISFInspection risk
eISF health
47 waiting to be filed.
Unfiled47
Approvals73
Consent25
Equipment70
Laboratory49
Monitoring46
Protocol and IB49
Safety49
Staff and training117
Illustrative. Sample data.
- 08:30 Today's visits and missing documents, at a glance
- 09:10 Consent signed on a tablet, filed with its audit trail
- 10:40 Visit completed; patient compensation triggered
- 11:15 Paper scanned straight into the right folder
- 14:00 The monitor reviews the site file remotely
Connects to the systems you already run.
Links to hospital systems through FHIR, DICOMweb, REST API, and webhooks.
- Runs on the database and operating system you already use
- On-premise, hybrid, or cloud, as your hospital chooses
- Open export to your statisticians' own tools
See your capacity before you sign.
Every study's visits sit on one calendar, so you know your capacity before you accept a new trial.
SiteStudiesDocumentsData HubFinance
JN
September 2026
Today
All visitsPlannedDone
TodayDonePlanned
MonTueWedThuFriSatSun
31539-004 Randomisation579-004 C3D1
1574-001 Screening641-007 C5D1
2
3704-001 Week 8
4556-002 C5D1678-004 Week 12
5
6
7641-001 Screening579-008 C5D1
8483-009 Screening
9539-004 Randomisation579-004 C3D1
10197-002 Week 24556-003 C1D1
11574-001 Screening641-007 C5D1
12
13
14556-002 C5D1678-004 Week 12
15641-002 C3D1
16704-003 Week 2812-001 C6D1
17483-002 Week 16574-001 Screening
18641-001 Screening579-008 C5D1
19
20
21214-032 Week 2214-035 Screening
22539-004 Randomisation579-004 C3D1
23812-001 C6D1197-002 Week 24
24574-001 Screening641-007 C5D1
25556-002 C5D1678-004 Week 12
26
27
28641-001 Screening579-008 C5D1
29214-035 Screening214-002 Safety follow-up
30483-009 Screening539-004 Randomisation
1579-004 C3D1641-002 C3D1
2812-001 C6D1197-002 Week 24
3
4
Mon 28
641-001 Screening579-008 C5D1
Tue 29
214-035 Screening214-002 Safety follow-up
Wed 30
483-009 Screening539-004 Randomisation
Thu 1
579-004 C3D1641-002 C3D1
Fri 2
812-001 C6D1197-002 Week 24
Sat 3
Sun 4
Illustrative. Sample data.
Every step from first contact to close-out is timestamped, so your unit can show sponsors its start-up speed.
Staff see only what their role allows.
Each person sees only the studies, folders, and fields their role allows, and signs in with your hospital login.
Person A. Novak, study coordinator
- Sign-in
- Hospital single sign-on, with MFA
- Studies
- Three assigned
- Folders
- Site file, consent, visits
- Fields
- Patient identity hidden
- Approvals
- Cannot approve her own entries
Your team sets anonymisation folder by folder, and retention and deletion per deployment; LDAP and Active Directory are supported.
Workflows that follow your SOPs.
When a document changes, ZINOS routes it for review in the order your SOP sets, chases late sign-offs, and files the signed copy.
Workflow: consent form, version 4.2
- Review Study coordinator Done
- Approval Principal investigator Done
- Approval Quality lead Due in 2 days
- Escalation Head of unit If overdue
- Signed and filed Site file Next
Illustrative. Sample data.
Branching, parallel approval, escalation, and service-level monitoring, configured without code, with Python for advanced cases.
Remote monitoring, inside your system.
The monitor works inside your system, on what your team opened for that study, and every view is logged.
Review without the trip
The site file is reviewed remotely, under your permissions.
Records stay with you
Source records are viewed inside your system, where your hospital and the trial approval allow.
Only this study
Individual, read-only access to this study; other studies stay out of sight.
Inspection records, filed as you work.
Audit trail
Every change kept, with who, when, and why.
Training records
Staff training held against the current SOP version.
Version history
Every version of every document, never overwritten.
- ICH GCP
- 21 CFR Part 11
- EMA Annex 11
- ALCOA+
Built to GAMP 5, validation-ready, with supplier documentation your quality team can review.
See ZINOS with one of your own trials.
Book a call and bring one live trial; your DPO and IT lead can join later.