---
title: "UniCDM | Clinical Data Management System & EDC Software"
description: "CDMS/EDC platform for clinical trials: paper-first eCRF design, AI-assisted CRF import, Vietnamese, English and Japanese UI, SAE workflows and audit trail."
language: en-US
canonical: https://unicdm.com/en/
publisher: "OKAXI TECHNOLOGY SOLUTIONS CO., LTD."
site: "UniCDM"
---

# 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

UniCDM is owned and developed by OKAXI TECHNOLOGY SOLUTIONS CO., LTD.

## 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.

## 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.

### AI-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.

### Vietnamese, 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.

### Safe 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.

### SAE & 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.

### Tamper-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.

## The full study lifecycle in one system

More than 20 modules organised into four stages: Design → Operate → Monitor → Close.

### 1. Design: Study and eCRF design

- Form Builder & shared library
- CDISC standards data
- Visit schedule & form × visit matrix
- Edit checks & randomization
- Permissions & Go-Live checklist

### 2. Operate: Study conduct and data capture

- A4-style eCRF data entry
- Double data entry (DDE)
- Visit calendar & overdue alerts
- Safety / SAE
- Site & document management

### 3. Monitor: Quality control, SDV and reporting

- Query management
- Monitoring & field-level SDV
- Dashboards & reports
- Hash-chained audit trail
- Data Hub import/export

### 4. Close: Database lock and eTMF archive

- Study close-out checklist
- Soft lock, signed hard lock
- Per-site lock
- eTMF archive with SHA256SUMS

## UniCDM module groups

### 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 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

## 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.

**A note on compliance:** UniCDM is designed to support compliance with 21 CFR Part 11 and ICH-GCP. It has not been certified by a regulator or an independent validation body. Compliance for any given study also depends on the using organisation's validation, SOPs and configuration.

## 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

- Download on the App Store (iOS): https://apps.apple.com/app/unicdm/id6822803547
- Get it on Google Play (Android): https://play.google.com/store/apps/details?id=com.unicdm.app
- Web application: https://app.unicdm.com/

## Frequently asked questions

### 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.

## 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.

- Contact email: info@okaxi.com (UniCDM demo request)

To help us respond faster, please include:

- Your name and role
- Your organisation (sponsor, CRO, hospital, research centre…)
- Study type and main needs (for example number of sites, languages, mobile app)
- Times that suit you for a demo

Please do not send patient information or study data by email.

## Company

- Legal entity: OKAXI TECHNOLOGY SOLUTIONS CO., LTD.
- Website: https://okaxi.com/
- Email: info@okaxi.com
- Country: Vietnam
- Privacy Policy: https://unicdm.com/en/privacy/
- Terms of Service: https://unicdm.com/en/terms/
- App Privacy Policy: https://unicdm.com/en/app-privacy/