Contact us
EDC · ePRO · IWRS · CDISC

Clinical data
engineering

We build our own software and handle study data end to end – from electronic database design to the statistical report and CDISC datasets. Accurate, traceable, GCP-compliant.

✓ GCP · 21 CFR Part 11 ✓ Encryption · access control ✓ Full audit trail
eCRF · protocol VQ-2026-014 · visit V3 LIVE
Subject 04-017 Site 04, Hong Kong Form Vital signs
DATA COMPLETENESS 0%
AUDIT TRAIL
Data under control
validation and audit at every step
Study data lifecycle from protocol to regulatory submission – in one system
How it works from the patient visit to a clean database
Research site: a physician enters patient visit data on a tablet 01 · Visit
Data captured at the source
Investigators enter measurements during the patient visit – no paper CRFs and no double data entry.
Completing an electronic case report form on a tablet 02 · Electronic CRF
Checked at entry
Every field is validated against the protocol rules as it is entered, so discrepancies never get deep into the database.
Laboratory: sample handling and monitors showing study data charts 03 · Lab and analysis
A single data stream
Lab results and instrument exports flow into the database automatically and are reconciled with the entered data.
Services

End-to-end clinical data management

We take care of study data at every stage – from the initial database design to the documents for regulatory submission. Every operation is recorded and traceable.

Product

Vivideq EDC – our electronic data capture platform

Our own web platform for electronic data capture and eCRF management. It runs in the browser, needs no installation and is available to sites anywhere in the world.

Monitor · database VQ-2026-014 Open queries: 7
VISITS
V1 · Screening
V2 · Randomization
V3 · Treatment, wk 4
V4 · Treatment, wk 12
V5 · End of study
Sites · 12
Subjects · 248
Records · 41,802
ENTERED
96.4%
QUERIES
7
SDV
88%
FORMSTATUSUPDATED
Vital signs signed 09:44
Adverse events 2 queries 09:31
Concomitant medications coded 08:57
Laboratory data importing 08:40
Treatment adherence signed yesterday

Real-time data capture

Investigators enter data during the patient visit, and the system instantly checks it for completeness and consistency. Coordinators and monitors always see the current state of the study.

✓Compliant with 21 CFR Part 11
✓Immutable audit trail of every change
✓Role-based access control
✓Electronic signatures and version control
✓Built-in monitoring and query management
Project cost
Quoted per study
The final price depends on the number of sites, subjects and visits and on the complexity of the data structure. Every estimate is prepared individually.
9:41▮▮▮
Patient diary
Day 28 · protocol VQ-2026-014
Rate your pain over the last 24 hours
0 1 2 3 4 5 6 7 8 9 10
no painworst pain
Morning dose
Taken Missed
Reminder: visit V4 – October 12, 10:30
Submit diary
COMPLIANCE
94%
26 of 28 days completed. Missed days are flagged to the monitor automatically.

Electronic patient diary (ePRO)

Patients complete questionnaires and a symptom diary on their own smartphones and get reminders about visits and doses. The data goes straight into the study database – no paper and no re-entry.

✓A clear interface for patients of any age
✓Reminders and compliance tracking
✓Validated scales and questionnaires
✓One database shared with EDC
Primary endpoint ITT · n=248 · ADaM ADEFF p = 0.014
BLWk 4Wk 12Wk 24Wk 52
Investigational product Placebo
TLFs DONE
142 / 156
SDTM DOMAINS
23
DEFINE-XML
valid

Analysis and reporting

From the statistical analysis plan to a complete set of tables, listings and figures. We prepare standardized CDISC datasets and materials for regulatory submission.

✓Statistical analysis plan (SAP)
✓Tables, listings and figures (TLFs)
✓SDTM and ADaM datasets
✓Support in preparing the clinical study report
Why us

Compliance, security and traceability

Our processes are designed so that study data stays protected and every action is justified and documented.

01

GCP standards

We follow the principles of Good Clinical Practice at every stage of a project.

02

21 CFR Part 11

Electronic records and signatures with integrity control and an audit trail.

03

CDISC standards

SDTM, ADaM and Define-XML datasets prepared for regulatory submission.

04

Data security

Encryption, access control, backups and activity monitoring.

About us

Vivideq

We are a team of software engineers and clinical data management specialists. We build our own software for clinical research and deliver turnkey data processing. The engineering reliability of the system matters to us as much as the accuracy of every record in the database.

✓In-house development, no off-the-shelf third-party systems
✓Flexible configuration for each study protocol
✓Support throughout the entire project
Python PHP JavaScript PostgreSQL

The platform scales to studies of any size and evolves with the requirements of our projects.

Clinical data management team at work Data management team
Contact

Tell us about your study

Describe your project and we will estimate the scope of work and propose a solution. We reply on business days.

Email us →
2 Queen’s Road Central, Hong Kong

What to include in your email

This is enough for an initial project estimate.

01Study phase and type
02Approximate number of sites and subjects
03Services needed: EDC, ePRO, coding, statistics, CDISC
04Expected start date