A first release covering participant enrolment, ePRO data collection and site coordination for a single study typically starts around $22,000, with a discovery and specification phase from $3,500 credited against the build. Multi-study, multi-site platforms with sponsor dashboards and advanced monitoring are quoted after discovery. Compared against per-participant or per-site SaaS licensing on international CTMS platforms over the life of a multi-year trial, custom is frequently the more predictable cost.

Australian data centres by default, or on-premise inside your institution or sponsor organisation if your governance requires it. Participant health information under the Privacy Act 1988 is materially simpler to govern when it stays in Australian jurisdiction — most established CTMS and ePRO platforms are hosted offshore, which adds a layer of cross-border data transfer assessment most sponsors would rather avoid.

We build to support them. TGA clinical trial notification (CTN) and clinical trial exemption (CTX) scheme record-keeping, HREC-approved protocol version control, and audit-ready electronic records are built into the data model from the start, rather than retrofitted. Ethics approval always sits with your HREC and trial conduct with your sponsor — the platform's job is to make that oversight demonstrable.

Electronic Patient (or Clinician) Reported Outcomes — participants or clinicians enter outcome data directly through a secure app or portal instead of paper diaries or phone calls. It reduces transcription error, gives sites real-time visibility into participant status, and produces a clean, timestamped, audit-ready dataset instead of a shoebox of paper forms transcribed weeks later.

Yes — that's the core design. Participants can complete outcome reporting, consent renewal and scheduling remotely, with site staff and sponsors monitoring status in real time rather than only at scheduled visits. Fully remote, hybrid and traditional site-based designs are all supported; you're not locked into one model.

Consent is recorded against the participant and the specific protocol version, with re-consent workflows when a protocol amendment changes what a participant agreed to. Withdrawal is tracked and propagates to reporting — a withdrawn participant's future data collection stops immediately and the audit trail records exactly when and why.

Yes. Role-based access separates what a participant, a site coordinator, a principal investigator and a sponsor monitor can each see and do, across as many sites as the trial runs at. Sponsors get real-time enrolment and data-quality visibility without needing to phone each site for a status update.

We can produce the documentation needed to support system validation — requirements traceability, test scripts and results, and change control records, aligned to the kind of evidence a monitor or auditor expects for electronic systems used in a clinical trial. The validation and audit itself is performed by your quality team; we supply the evidence they need.

A first release covering one study — enrolment, ePRO collection, site coordination — typically takes ten to fourteen weeks after a two-to-three week discovery phase. We deliver in phases so sites can start enrolling before every sponsor-facing feature is finished.

Yes — source code, documentation and infrastructure, in your organisation's name. There's no per-participant or per-site licence to us, and no dependency that could strand a multi-year trial partway through if you ever needed to move to another developer.

Yes — REDCap or other EDC exports, hospital or clinic patient management systems, and reporting tools your sponsor already uses. We scope integrations during discovery so the data flows you actually need are built in from day one, not bolted on afterward.

Yes, Australia-wide. Discovery and most build phases run remotely; for multi-site trials we typically recommend at least one on-site session with a coordinating site to see the real enrolment and visit workflow before finalising the design.