Get
Clinical Trial
At
galaxbiotech.com
Galax EDC is our flexible electronic data capture platform built specifically for global clinical trials. With configurable eCRFs, library-based templates and strong version control, you can move from protocol to first patient in weeks, not months. Clean, intuitive forms help sites work faster while reducing data-entry errors.
Built on CDISC-aligned structures, Galax EDC supports complex visit schedules, dosing schemes and derived endpoints without sacrificing usability. Real-time edit checks, role-based access and a complete audit trail keep you inspection-ready at every stage. Whether you run a single-country study or a global program, Galax scales with you.
We capture clinical data that’s clean, compliant and ready for analysis.
Every capability your study needs, from metadata to export — lettered A through L, the way your data flows.
Stand up studies quickly with a structured, metadata-driven approach. Configure sites and countries, define visit schedules that mirror the protocol — including unscheduled visits — and reuse validated eCRF templates from a central form library. Version control and amendment handling deploy mid-study changes in a controlled, auditable way without disrupting data entry.
Design protocol-exact forms with an intuitive drag-and-drop builder. Configure field-level validations, dynamic fields, and conditional logic; derive values automatically with calculated fields; handle con-meds, AEs, and lab panels with repeating forms. Preview every form exactly as sites will see it — what you approve in UAT is what goes live.
Give sites a clean, fast entry experience. Visit-wise navigation guides coordinators through each subject's schedule with partial save, structured missing-data reasons, and clear form status — not started, incomplete, complete, reviewed, locked. Built-in SDV/SDR support keeps monitoring organized in the same workflow.
Catch discrepancies at entry, not months later. Range, date-logic, and mandatory-field checks fire in real time, while cross-form and cross-visit checks verify consistency across the whole subject record — AE dates against dosing, visits against windows. A custom edit-check builder lets data managers define, test, and version study-specific checks without programming.
Keep cleaning moving with a fully structured query lifecycle. Manual and system-generated queries are assigned, answered, re-queried, and closed with complete history. Aging metrics and a dedicated dashboard show exactly where effort is needed, while notifications replace email chains.
Code adverse events, medical history, and medications consistently with MedDRA and WHO Drug support. Verbatim terms flow into a structured queue where coders assign, reviewers approve or return, and every decision lands in the audit trail. Dictionary versioning and recode workflows keep coding aligned across the study.
Bring central and local lab data in without transcription. Configure reference ranges by lab, age, and sex; flag abnormal and clinically significant values automatically; keep units consistent with built-in conversion. Validated results auto-populate lab eCRFs, cutting entry and reconciliation effort.
Capture adverse events with the structure safety teams need — severity, causality, outcomes, and exposure linkage. A dedicated SAE workflow supports expedited handling, medical review, and stakeholder notification, with reconciliation tooling and integration points for pharmacovigilance systems including Galax Safety.
Control exactly who sees and does what. Fine-grained roles govern access at study, site, and form level — monitors see their sites only; coordinators enter data but never touch configuration; statisticians read but never write. MFA-ready architecture, password policies, session timeout, and lockout controls align with GxP expectations.
Every action leaves a defensible record: complete audit trail for create, update, and delete with user identity, timestamp, old and new values, and reason for change. E-signatures support investigator sign-off. Designed to support 21 CFR Part 11 requirements and ICH-GCP aligned conduct, built on GxP and ALCOA+ principles.
See the state of your trial at a glance: enrollment against targets, form completion by site and visit, query volumes and aging, missing data, SDV/SDR progress. Site performance views highlight where attention is needed, and lock-readiness indicators show exactly what stands between you and a clean database.
Get data out in the format downstream teams need: Excel, CSV, and SAS-ready exports on demand, with CDISC-ready structures that accelerate SDTM preparation. Integration points connect Galax EDC with IWRS, eTMF, ePRO/eICF, Galax Safety, and LUP Analytics for CDISC transformation, statistics, and reporting.
Clinical trials fail quietly — a lagging site here, an aging query there, a missing visit no one noticed. Galax dashboards surface these signals the moment they appear:
3 open queries · 2 unsigned casebooks
12 forms pending SDV
Galax EDC is engineered around the regulatory expectations that govern clinical trial data.
Electronic records, e-signatures, audit trails, and access controls built into the platform architecture.
Controlled workflows, investigator oversight, and documented data review consistent with E6 expectations.
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available.
Complete audit trails, reason-for-change capture, versioned metadata, and access records on demand — with validation-friendly documentation for your CSV activities.
Compliance is a shared responsibility: Galax EDC provides the technical controls and documentation to support your regulated processes; certification claims are made only where formally established.