Role-based access
Participant and study-team access is separated according to the configured trial workflow.
ePROPatient-reported outcomes
Make the patient experience part of the evidence chain.
Galax ePRO supports structured collection of participant-reported outcomes within the connected Galax clinical platform. Study teams can configure assessments, schedule completion and monitor incoming patient data alongside the wider trial workflow.
- Direct
- Participant data capture
- Timely
- Assessment scheduling
- Linked
- EDC-ready evidence flow
Capabilities
Patient-reported data—captured clearly, monitored centrally and ready for review.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Instrument design
Build diaries and questionnaires, preview them as the patient sees them, publish to QC and release to Live; DEV, QC and Live environments never mix.
- 02
Schedules, windows & reminders
Align entries with visits and treatment periods using schedules, completion windows and in-app reminders.
- 03
Translations
Enter translated text, run the translation workflow and approve each language before the release check.
- 04
Patient app
Patients activate with a code, sign in with a PIN and complete entries on phone, tablet or computer, with an inbox for messages; sites can also enter data in interview mode.
- 05
Compliance & clinical alerts
Follow compliance per patient and site with a diary calendar and 12-week trend, and act on clinical alerts raised from patient answers.
- 06
Data change requests
Correct patient data only through a change request that is raised, decided and signed, keeping the original entry attributable.
- 07
Messages, training & devices
Message patients and sites with templates, record patient training and onboarding checklists, and track devices, replacements, app versions and last sync.
- 08
Data quality & export
Run data-quality checks, review findings and site performance, then export CDISC ODM-XML, an ODM-style flat file or SDTM QS, and reconcile ePRO values with mapped EDC items.
How it works
One accountable path from set-up to evidence.
Connect ePRO with Galax EDC, clinical data management and LUP Analytics so participant-reported information remains part of the same traceable evidence chain.
- 01
Configure
Build protocol-defined assessments and response structures.
- 02
Schedule
Align participant tasks with visits and assessment windows.
- 03
Capture
Collect structured participant-reported information directly.
- 04
Review
Monitor completeness and transfer data into clinical analysis.
Quality and control
Designed for regulated clinical work.
Platform controls and documented procedures support the sponsor's validated, risk-based use.
Time-stamped records
Assessment timing and completion status remain visible for review and follow-up.
Controlled study setup
Questionnaires, schedules and changes are maintained through defined configuration controls.
Integrated evidence
Structured data connects with EDC and downstream clinical data and analysis processes.
Who uses it
- Patient
- CRC
- Data manager
- CRA
- Sponsor
Contact
See Galax ePRO on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.