CDMS/EDC platform for clinical research
Clinical data management, from the first CRF to database lock.
UniCDM brings eCRF design, data capture, quality control and study close-out into one platform, with AI assistance and a user interface in Vietnamese, English and Japanese.
- Design once: print on paper, enter on the web
- AI suggests, people approve
- iOS & Android apps save drafts offline
Solutions
Familiar obstacles in clinical data management
UniCDM is built around how studies actually run at hospitals and research sites, where paper CRFs, Word files and disconnected tools are still common.
Common today
Paper CRFs and eCRFs are two separate artefacts, built twice and prone to drifting apart.
With UniCDM
Design once on a true A4 canvas. The same design produces the web entry form and the printable PDF.
Common today
Sponsors send CRFs as Word documents, and data managers rebuild every field by hand.
With UniCDM
AI reads the Word file, splits it into forms and suggests field types and CDASH/SDTM mappings. Your team reviews and decides.
Common today
English-only systems are hard to use for site staff.
With UniCDM
Interface and form content are available in Vietnamese, English and Japanese. AI translates form content; reviewers confirm it.
Common today
Randomization, SAE tracking and BI reporting each need a separate tool for the same study.
With UniCDM
Randomization, SAE management, dashboards and database lock are built into one platform, sharing one audit trail.
Key features
Six capabilities that set UniCDM apart
Built-in capabilities that reduce manual work and keep data consistent from study design to database lock.
Paper-first CRF
Drag and drop fields on a real A4 canvas: multiple pages, portrait or landscape, headers/footers, "Page X of N" numbering and automatic page breaks.
- Web form and PDF from one design
- Bilingual CRF and aCRF with one switch
- CRF Book: every form in one PDF
The printout matches the screen, which suits sites that record on paper first.
See details: Paper-first CRFAI-assisted eCRF
Upload a Word CRF (.docx, up to 25 MB). AI splits it into forms, detects field types and suggests CDASH/SDTM mappings.
- Draft opens in the Form Builder for review
- Processing runs in the background on the server
- AI translates form content as a draft for review
AI only makes suggestions. People review, edit and approve them.
See details: AI-assisted eCRFVietnamese, English and Japanese
Not just the interface: form content, choice lists and edit-check messages are maintained separately for each language.
- Layouts handle Vietnamese text length and Japanese line breaking
- Mobile apps support all three languages
- Built-in help in three languages
Site staff enter data in their own language.
See details: Vietnamese, English and JapaneseSafe study amendments
Every publish creates an immutable version, and each record stays linked to the form version it was created with.
- Changes classified as Breaking / Restricted / Display-only
- Impact analysis before publishing
- Data dropped in migration is archived verbatim
Know the consequences of a change before it goes live, and keep historical data intact.
See details: Safe study amendmentsSAE & safety workflow
Countdown clocks start when the investigator becomes aware of the event, following the 24-hour, 7-day and 15-day ICH E2A timelines.
- Status: On time / Due soon / Overdue / Completed
- Repeat reminders by email and in-app
- Electronic signatures that cannot be overwritten
A clear view of internal SAE reporting deadlines.
See details: SAE & safety workflowTamper-evident audit trail
Each audit entry contains the hash of the previous one (hash chaining). An "Integrity check" pinpoints where the chain is broken, if anywhere.
- Editing submitted data requires a reason
- Entries without a reason are flagged
- Audit trail export to CSV
Every change leaves a verifiable trace.
See details: Tamper-evident audit trail
Workflow
The full study lifecycle in one system
More than 20 modules organised into four stages: Design → Operate → Monitor → Close.
Design
Study and eCRF design
Key modules
- Form Builder & shared library
- CDISC standards data
- Visit schedule & form × visit matrix
- Edit checks & randomization
- Permissions & Go-Live checklist
Operate
Study conduct and data capture
Key modules
- A4-style eCRF data entry
- Double data entry (DDE)
- Visit calendar & overdue alerts
- Safety / SAE
- Site & document management
Monitor
Quality control, SDV and reporting
Key modules
- Query management
- Monitoring & field-level SDV
- Dashboards & reports
- Hash-chained audit trail
- Data Hub import/export
Close
Database lock and eTMF archive
Key modules
- Study close-out checklist
- Soft lock, signed hard lock
- Per-site lock
- eTMF archive with SHA256SUMS
Capabilities
UniCDM module groups
Choose a group to see its capabilities.
Study Design
Build studies and eCRFs quickly and consistently, with version control.
- Form Builder
- 19 field types (including matrix, dynamic table, GPS and photo); conditional visibility and requirement; A4 print, aCRF and bilingual output.
- AI Word import
- Splits a .docx into forms and suggests field types and CDASH/SDTM mappings; the draft waits for user review.
- Shared library
- Question bank, code lists and eCRF templates reusable across studies.
- CDISC standards data
- Load official SDTMIG/CDASHIG files and browse domains and variables.
- Study structure
- Visit schedule (required, optional, unscheduled), visit windows, form × visit matrix, repeating forms such as AE and concomitant medication.
- Versions & CRF Book
- Version publishing, impact analysis, CRF Book PDF and data dictionary for SAS/R.
- Randomization & blinding
- Simple, block and stratified; open-label, single- and double-blind; reproducible seed; drug kit management; emergency unblinding with reason and audit.
- Configuration & Go-Live
- Subject ID templates, automatic form locking, single/double entry; readiness checklist before the one-way switch to production.
Data Collection
Data entry on forms that mirror the paper CRF, in the user's language.
- eCRF data entry
- Full-screen A4-style entry; field-level notes and queries; only subject initials are stored.
- Double data entry (DDE)
- Two independent passes, third-party reconciliation, discrepancies raise queries automatically.
- Visit calendar
- Day/week/month views and per-subject timelines; alerts for overdue or upcoming visits.
- Device capture
- GPS fields are rounded before storage; photo fields limit the number of images and require confirmation that photos are de-identified.
- Multilingual forms
- Form content, choices and error messages per language: Vietnamese, English, Japanese.
- Sites & documents
- Site status, enrolment targets, responsible PI; document repository by type with version history.
Data Quality
Validation rules and safe change management.
- Edit checks
- Within-field, cross-field and cross-form rules at three levels: block save, warn, or raise a query.
- Rule tester
- Enter sample values and see instantly whether a rule fires, without touching real data.
- Calculated fields
- SUM, AVG, ROUND, DATEDIFF and more; age calculated correctly by birthday.
- Conditional visits/forms
- Open visits or forms based on the full subject record, e.g. "open the unscheduled visit only when an SAE exists".
- Query management
- Open → Answered → Closed; alerts for queries open more than 7 days; auto-query rules.
- Amendment management
- Impact analysis before publishing; migrate existing records one by one with a preview of answers that would be lost.
Safety Management
Deadline-driven SAE tracking with reminders and electronic signatures.
- Reporting clocks
- 24-hour notification; 7 days for fatal/life-threatening cases; 15 days for other serious cases. Deadlines are counted from investigator awareness.
- Reminders
- Repeat reminders every 2/4/8 hours by email and in-app.
- Classification & coding
- Automatic SUSAR flagging; MedDRA coding support¹ and CTCAE v5 grading.
- Electronic signatures
- Password re-entry, stated signature meaning, cannot be overwritten.
- Internal review workflow
- IRB submission is blocked until sponsor notification is recorded; the screen shows exactly which step is blocking.
Monitoring & Analytics
SDV, monitoring reports and role-based dashboards.
- Monitoring & SDV
- Field-level source data verification; monitoring visit reports (MVR) with PI sign-off; prioritised site action items.
- Dashboards & reports
- Build charts, KPIs and targets; generate dashboards automatically from forms; share by role.
- Risky permission alerts
- For example: a "read-only" role with write access, a lock role that is not DM/PI, or a member with access to every site.
- Audit trail
- Hash-chained log, integrity check, CSV export.
Data Export & Study Closure
Export data for analysis and lock the database under control.
- Data Hub
- Export to CSV, Excel, SPSS and SAS; CDISC ODM import/export; import from Excel/CSV; preview before export.
- Close-out checklist
- No open queries, forms locked, SAEs closed, SDV complete, documents in place. Only then is the database hard-locked.
- Database lock
- Soft lock and signed hard lock; time-limited unlock that re-locks automatically; per-site lock.
- eTMF archive
- Signed zip package: eCRF data, sealed audit trail, documents and a SHA256SUMS file for verification.
Platform foundations
- Single sign-on (SSO) with Google/Microsoft
- Two-factor authentication (TOTP) and session management
- Light/dark themes, quick subject search with the "/" key
- Built-in help in three languages
- File storage on AWS S3, MinIO, Supabase or on-premises servers
¹ Using the full MedDRA dictionary requires your organisation to hold a valid MedDRA licence from the MSSO.
Who it's for
Who is UniCDM for?
Every study role gets a workspace that fits, with permissions scoped by role, site and individual form/visit.
Sponsor / CRO
One platform instead of many disconnected tools.
- Randomization, SAE, SDV, dashboards and database lock in one system
- CDASH/SDTM mapping and CDISC ODM import/export
- Dashboards tracking progress across all sites
Data Manager
Fast design, safe amendments, checklist-driven lock.
- Build forms quickly with AI and the shared library
- Impact analysis before publishing a new version
- Export to SAS, SPSS and CDISC ODM; lock with a checklist
Principal Investigator
Track reporting deadlines and sign off in the system.
- E-sign SAEs and monitoring visit reports
- Countdown clocks for SAE deadlines
- A clear view of site action items
Clinical Research Coordinator
Enter data in your own language, on forms that match the paper CRF.
- Web forms laid out like the paper CRF
- Mobile data entry with offline drafts (mobile app)
- Reminders for upcoming and overdue visits
Clinical Research Associate
SDV and monitoring reports without external tools.
- Field-level SDV directly on the eCRF
- Write monitoring visit reports (MVR) in the system
- Track site action items by priority
System Administrator
Control access and storage infrastructure.
- SSO, 2FA and session management
- System logs and bulk user import
- Choose file storage: S3, MinIO, Supabase or on-premises
Suitable study types
- Phase I–IV clinical trials
- Observational studies
- Investigator-initiated studies at hospitals
- Community studies that need GPS and photos
Compliance & security
Designed to support compliance and protect data integrity
Controls built into the product help your organisation meet the requirements of clinical research.
Designed to support 21 CFR Part 11
Electronic signatures, audit trail and mandatory reasons when changing submitted data.
ICH-GCP-aligned workflows
AI translations await reviewer approval, PIs sign off monitoring reports, SAE timelines follow ICH E2A.
CDISC support
CDASH/SDTM mapping suggestions, SDTMIG/CDASHIG loading, CDISC ODM import/export.
Hash-chained audit trail
Each entry links to the previous one; the integrity check pinpoints any break.
Three-layer access control
Role × site × individual form/visit, with automatic alerts on risky permission setups.
Single sign-on (SSO)
Sign in with your organisation's Google or Microsoft account.
Two-factor authentication
TOTP codes and session management.
Electronic signatures
Password re-entry and stated meaning; signatures cannot be overwritten.
Server-side blinding
Treatment arms are removed from returned data, not just hidden on screen.
Mobile apps
Data entry at the site, even with patchy connectivity
The UniCDM apps for iOS and Android let site staff and monitors work directly on their phones.
Offline drafts
Enter eCRF data and save drafts on the device without a connection.
Automatic sync
Drafts sync automatically once the connection is back.
Visit schedule
See upcoming visits and receive push notifications.
Queries & SDV
Answer queries and perform SDV on the phone.
AE/SAE tracking
Record AEs/SAEs with a 24-hour countdown.
Biometric unlock
Fast, secure sign-in; available in Vietnamese, English and Japanese.
Offline data entry is available in the mobile apps only. The web application requires an Internet connection.
Get the UniCDM app
Scan the QR code with your phone camera or tap a button to download UniCDM for iOS and Android.
- iOSScan to downloadDownload on the App Store
- AndroidScan to downloadGet it on Google Play
Web application
Already have an account? Sign in to UniCDM in your browser.
FAQ
Frequently asked questions
Can't find what you need? Get in touch with us.
What is UniCDM?
UniCDM is a clinical trial data management platform (CDMS/EDC) covering the full study lifecycle: eCRF design, study conduct and data capture, quality control, database lock and archiving. UniCDM is owned and developed by OKAXI TECHNOLOGY SOLUTIONS CO., LTD.
Which organisations is UniCDM for?
Sponsors, CROs, hospitals and research centres. It suits phase I–IV clinical trials, observational studies, investigator-initiated studies at hospitals and community studies that need GPS and photos.
Does UniCDM support Vietnamese?
Yes. The interface, form content, choice lists and edit-check messages are available in Vietnamese, English and Japanese. AI can translate form content; translations stay marked as "draft" until a reviewer confirms them.
Can I convert a Word CRF into an eCRF?
Yes. Upload a .docx file (up to 25 MB); AI splits it into forms, detects field types and suggests CDASH/SDTM mappings. The draft opens in the Form Builder for your team to review and approve. AI features run through an external AI service and can be turned off.
Does UniCDM support CDISC?
UniCDM suggests CDASH/SDTM mappings during form design, loads official SDTMIG/CDASHIG files to browse domains and variables, and supports CDISC ODM import/export. Data can also be exported to CSV, Excel, SPSS and SAS.
Can I use UniCDM on a phone?
Yes. The iOS and Android apps support eCRF entry, SDV, queries, AE/SAE, the visit schedule and push notifications, in all three languages.
Can I enter data without an Internet connection?
Yes, in the mobile apps: eCRF data is saved as a draft on the device and syncs automatically when the connection returns. The web application requires an Internet connection.
How does UniCDM handle security and data control?
UniCDM provides a hash-chained audit trail with an integrity check, access control by role × site × form/visit, single sign-on with Google/Microsoft, two-factor authentication (TOTP), electronic signatures and server-side blinding. Changing submitted data requires a reason.
Is UniCDM certified for 21 CFR Part 11?
UniCDM is designed to support compliance with 21 CFR Part 11 and ICH-GCP, but it does not hold a certification or an independent validation report. Compliance for each study depends on the using organisation's validation and SOPs.
Does UniCDM support MedDRA coding?
UniCDM supports MedDRA coding in its safety workflow. Using the full MedDRA dictionary requires your organisation to hold a valid MedDRA licence from the MSSO.
How do I request a demo?
Email info@okaxi.com with the subject "UniCDM demo request", including your name, role, organisation and study needs. The OKAXI team will reply to arrange a walkthrough tailored to your study.
Contact
Ready to simplify clinical research data management?
Email the OKAXI team to request a demo or discuss your study. We will reply and arrange a UniCDM walkthrough that fits your needs.
Email us to request a demoContact emailinfo@okaxi.com