EDC Software for Clinical Trials in Australia
TGA-recognized EDC for Australian sites, HRECs and CROs
Run CTN/CTX studies with an eCRF platform that matches TGA expectations, NHMRC ethics processes and Australian Privacy Principles — priced transparently in Australian dollars.
- Compliant audit trails & e-signatures
- Local-currency pricing: A$2 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
Australia is a preferred destination for phase I through phase III studies and one of the few markets offering both a mature ethics regime and government incentives for clinical trials. The Therapeutic Goods Administration (TGA) runs the CTN (Clinical Trial Notification) and CTX (Clinical Trial Exemption) schemes, while every sponsor must obtain approval from an accredited Human Research Ethics Committee (HREC) under the NHMRC National Statement.
For Australian sites, hospitals and CROs, the practical challenge is balancing rigorous governance with speed. Elysium Clinical Trials EDC gives teams a cloud eCRF environment that satisfies both: fast study setup, completely traceable data, and audit trails that HRECs and TGA inspection processes accept without friction.
This page explains the Australian regulatory framework, how Elysium fits it, and what the platform costs in Australian dollars.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in Australia.
TGA (CTN / CTX schemes)
The Therapeutic Goods Administration oversees clinical trials of therapeutic goods under the CTN and CTX schemes. Elysium supports the data-integrity and record expectations behind TGA oversight.
HREC & NHMRC National Statement
Every Australian trial requires accredited Human Research Ethics Committee approval. Versioned eCRFs, full audit trails and exportable records make HREC review and reporting straightforward.
Privacy Act 1988 (APPs)
The Australian Privacy Principles govern handling of personal information including health data. RBAC, encryption and audited access support APP compliance for health research.
ICH GCP E6(R2)
Sponsors of Australian trials expect the same GCP standard as any global study. Elysium’s query, SDV and monitoring features align to it.
Sponsors running Australian studies typically rely on the CTN pathway (sponsor-lodged notification to the TGA, combined with HREC approval). Because Elysium keeps the full data story — form versions, edits, signatures and queries — in one place, teams can pull together the documentation HRECs request at any point without reconstructing it from spreadsheets.
A Complete Electronic Data Capture Platform
Everything your study team needs, from first CRF draft to database lock and export.
Drag-free eCRF Builder
Design case report forms with validation, skip logic and required-field rules — no code.
Study & Subject Management
Manage sites, visits, subjects and ePRO/pROM instruments from one workspace.
Security & Access Control
Role-based permissions, two-factor-ready logins, encryption in transit and at rest.
Queries & SDV
Raise, answer and close queries; schedule source-data-verification tasks for monitors.
Audit Trail
Every edit, signature and query is attributed, time-stamped and non-destructive.
Export & Reporting
Export to CSV, Excel, JSON or CDISC ODM; API access for downstream pipelines.
Electronic Signatures
e-sign at form, visit or study level with full linkage to the signer and timestamp.
Randomization
Coding and allocation management with support for commonly used randomization schemes.
Medical Coding
MedDRA/WHO-Drug-style term coding within the same environment you enter data.
From Sign-Up to First Data in Three Steps
Create an Account
Sign up for a 14-day free trial. No credit card, no procurement delay — your team can explore immediately.
Build Your CRFs
Model your study, sites and visits, then assemble eCRFs with the visual builder — most studies are live within a day.
Enroll & Monitor
Invite site staff, enroll subjects, run queries and SDV, then lock and export when your database is clean.
Built for how research teams in Australia actually work
- Study environments ready for academic, clinical-trial-centre and commercial studies alike
- Single platform for single-site investigator-initiated studies to national multi-site trials
- Remote monitoring workflows suited to Australia’s distributed site geography
- Compliance-first data capture aligned to GCP and NHMRC standards
- Research tax incentive friendly record-keeping with full exportable history
- A$ local pricing so Australian finance teams can budget accurately
Australia’s research culture is rigorous and its costs are global rather than local — so efficiency matters. Elysium gives Australian sites and CROs a platform that removes data-entry friction, reduces query volume through built-in edit checks, and lets sponsors see clean, audit-ready data from day one.
Pricing for Australia in Australian Dollar
Transparent, local-currency figures so you can budget without doing the forex math. Billing on your invoice is in US dollars; equivalents are shown at the current rate.
Starter
For small studies and independent researchers
- 5 Studyies
- 50 Subjects
- 5 Users
- 2GB Storage
- Core EDC
- CSV Export and Import
- Audit Trail & Reports
- Internal Messaging System
- Query Management
Professional
For growing research teams and CROs
- 15 Studyies
- 500 Subjects
- 15 Users
- 5GB Storage
- REST API Access
- Core EDC
- CSV / Excel Export
- Audit Trail and Reports
- Internal Messaging System
- Query Management
Enterprise
For organizations running multiple concurrent studies
- 100 Studyies
- 5,000 Subjects
- 100 Users
- 25GB Storage
- REST API Access
- Core EDC
- All Exports / Import Options
- Audit Trail and Reports
- Query Management
- Priority Support
- Internal Messaging System
- Medical Coding (ATC/DDD, WHO ICD-10, LOINC)
- REST Api Access
- Desktop app (works offline as well)
Unlimited Plan
For large CROs and enterprise sponsors
- Unlimited Studyies
- Unlimited Subjects
- Unlimited Users
- 100GB Storage
- REST API Access
- All Advanced Features
- Dedicated Support
- Custom SLA
- Complete System Training
- Internal Messaging System
- Medical Coding (ATC/DDD, WHO ICD-10, LOINC)
- *Sensitive Medical Coding (medDRA and WHODrugs)
- REST API Access
- Desktop app (works offline as well)
Need a dedicated EDC built for your organization?
Custom study types, self-hosted or private-cloud deployment, local regulatory and language support, dedicated SLAs, SSO, and audit packs for Australia-based sponsors and CROs.
Questions about EDC for Australia
Does Elysium support TGA CTN and CTX trials?
Yes. Elysium is built for the record-keeping and data-integrity expectations behind CTN and CTX oversight: complete audit trails, electronic signatures and exportable records. Notification and approval are lodged with the TGA by the sponsor; Elysium covers the system side.
How does Elysium help with HREC review?
HRECs want to see that data will be accurate, attributable and protected. Elysium gives you versioned eCRF content, role-based access and complete audit trails you can present in your HREC submission, and clean reporting for continuing review.
Is our data handling APP-compliant?
Elysium supports the technical controls the APPs call for: access restricted by role and permission, data encrypted, and every action logged. Your organisation sets retention and handles notice obligations; we act as processor on your instructions.
Can we run a multi-site national study?
Yes. Add all sites under one study, delegate data rights per site, and keep a single central audit trail. Remote SDV and query workflows make coordinating NSW, VIC and QLD sites straightforward.
What are the Australian dollar prices?
This page shows AUD-equivalent figures for budgeting. Subscriptions are billed in US dollars with itemised invoices; see the pricing section for the current AUD numbers.
Elysium EDC in other regions
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