EDCClinical data capture

Clean clinical data—from protocol to database lock.

A flexible electronic data capture platform built for global clinical trials. Configurable eCRFs, reusable libraries and controlled versioning help study teams move from protocol to first patient in weeks, while intuitive forms and real-time checks improve data quality at entry.

VideoGalax EDC & eCRF: real product screens, sample study
Weeks
Protocol-to-go-live target
24
Modules on one platform
CDISC
Aligned data structures

Capabilities

Capture data that is clean, compliant and ready for analysis.

6 capability areas, all running under the same role-based access, electronic signatures and audit trail.

  1. 01

    Study setup & metadata

    Configure countries, sites, visits and unscheduled events through a structured, metadata-driven setup with reusable form libraries and controlled amendments.

  2. 02

    eCRF builder

    Design protocol-exact forms with conditional logic, calculated fields, repeating forms and a site-view preview for controlled UAT approval.

  3. 03

    Clinical data capture

    Guide sites through visit-wise entry, partial saves, structured missing-data reasons, clear form states and integrated SDV/SDR workflows.

  4. 04

    Edit checks & queries

    Apply field, cross-form and visit-level validation with a structured query lifecycle, aging views and clear ownership through resolution.

  5. 05

    Coding, labs & safety

    Support MedDRA and WHO Drug coding, central and local laboratory data, range flagging and AE/SAE review within the data workflow.

  6. 06

    Oversight & export

    Track enrolment, completion, query aging and lock readiness; export Excel, CSV and SAS-ready data in CDISC-aligned structures.

Modules

Every module in one validated EDC platform.

Build the study, run it, and open each connected application from the same study sign-in. Every module shares one role model, one set of e-signatures and one hash-chained audit trail.

Database programmers and data managers design, test and release the study in DBP and DV modes.

DES

Study design & form libraries

Versioned study designs built from reusable, controlled forms.

  • Form designer with 13 item types, code lists, ranges, units, partial dates and CDASH/SDTM variables
  • Arms, visits with day and windows, form versions and schedule of activities
  • Global, client and sponsor form and study-schema libraries
  • Draft → Published → Superseded/Retired versioning, clone and pull from global
  • Study data on MongoDB, PostgreSQL or Oracle, chosen per study
SET

Study setup

Events, sites, subjects, treatments and form assignment configured through metadata.

  • Events, timepoints, epochs, categories and initiation order
  • Event schemas per site, site metadata and site documents
  • Screen-failure and discontinuation reasons with subject metadata
  • Treatments and crossover sequences by period
  • Initiate, event, unscheduled and special form assignment
CHK

Edit checks & derivations

Validation rules and derived values that are tested and documented.

  • Program, test, scan and document edit checks (DVP)
  • Form, cross-form and visit-level scope
  • Standard derived variables: BMI, BSA, age, study day, QTc, eGFR and more
  • Assigned variables copied from a global, current or selected visit
REL

Validation & release

Controlled path from test data to a Live study.

  • Test data and datasets in DBP mode
  • Publish to QC, then UAT with a test plan generated from the design
  • UAT evidence, defects and e-signed sign-off
  • Deviation rules defined in build and detected automatically in conduct
  • Approval for Live and a study audit trail of every design change

How it works

One accountable path from set-up to evidence.

Connect Galax EDC with IWRS, eTMF, ePRO/eICF, Galax Safety and LUP Analytics for one continuous evidence workflow.

  1. 01

    Interpret

    Translate protocol objectives and schedules into a controlled data strategy.

  2. 02

    Configure

    Build eCRFs, validations, roles, reports and integrations.

  3. 03

    Validate

    Execute documented review and UAT before production release.

  4. 04

    Operate & lock

    Monitor, clean, reconcile and close the database with traceability.

Quality and control

Designed for regulated clinical work.

Platform controls and documented procedures support the sponsor's validated, risk-based use.

21 CFR Part 11 support

Electronic records, e-signatures, audit trails and controlled access are built into the platform architecture.

ICH-GCP aligned

Controlled workflows and documented investigator oversight support regulated trial conduct.

GxP & ALCOA+ principles

Data controls support attributable, legible, contemporaneous, original and accurate records.

Inspection readiness

Versioned metadata, reason-for-change capture and access records remain available for review.

Who uses it

  • Database programmer
  • Data manager
  • CRC
  • Investigator
  • CRA
  • Medical monitor
  • Sponsor

Pricing

Licence fee by study type.

Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.

Rate card GLX/RATE/2026-27/003.

Contact

See Galax EDC & eCRF on your protocol.

Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.