EDC Software for Clinical Trials in Canada
Health Canada-aligned EDC for Canadian sites, sponsors and REBs
Run compliant eCRF data capture across Canadian sites — with the documentation standards Health Canada and TCPS 2 expect, priced transparently in Canadian dollars.
- Compliant audit trails & e-signatures
- Local-currency pricing: C$1 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
Canada accounts for a meaningful share of global clinical research, processing thousands of trials a year across academic hospitals, community clinics and commercial CROs. Any trial using an investigational drug here falls under Health Canada’s Food and Drug Regulations (Division 5), while every institution applies the Tri-Council Policy Statement (TCPS 2) through its Research Ethics Board.
The operational reality for Canadian teams is a patchwork of provincial privacy laws, bilingual forms and demanding sponsor monitoring schedules. Elysium Clinical Trials EDC cuts through the complexity: one cloud platform to build eCRFs, manage subjects, chase queries and lock a defensible database — without a multi-month IT project.
This page outlines the Canadian regulatory picture, how Elysium supports it, and what the platform costs in Canadian dollars.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in Canada.
Health Canada (Division 5, Food and Drug Regulations)
Health Canada must review and provide a No Objection Letter before a clinical trial of a drug can start in Canada. Elysium supports the data-integrity and record requirements that come with those authorisations.
TCPS 2 & Research Ethics Boards
The Tri-Council Policy Statement governs research involving humans; every institution runs a REB. Clean, versioned records and complete audit trails support REB review and annual progress reporting.
PIPEDA & provincial privacy laws
PIPEDA applies to commercial research while provinces such as Ontario (PHIPA) and Alberta/British Columbia (PIPA) add health-specific duties. Role-based access, encryption and audited access logs are built in.
ICH GCP E6(R2)
Query management, SDV and monitoring features align the platform with the GCP standard Canadian sponsors and CROs write into their agreements.
Canadian trials often involve both federal and provincial layers, and many sites operate under CTA-issued No Objection Letters with REB oversight. Elysium is deliberately jurisdiction-friendly: you keep data access granular per site and role, maintain one trail for federal inspection and REB audit alike, and can support French and English content in the same study for Quebec sites or bilingual consent workflows.
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 Canada actually work
- Division 5-ready record trails with attributable, contemporaneous data capture
- REB-friendly transparency: every form version and data change is logged and visible
- English and French forms in the same study for bilingual Canadian sites
- Remote monitoring and SDV workflows built for Canada’s geography
- Per-province data delegation for multi-province studies under one environment
- No installation at sites — data managers get the same URL from enrolment to lock
Sponsors choose Canadian sites for quality, and Canadian sites deserve tools that reflect the quality they deliver. Elysium gives academic hospitals, community sites and CROs a modern eCRF platform at a fraction of legacy licence costs, with local-currency clarity for budgeting and approval through finance teams that often need CAD figures.
Pricing for Canada in Canadian 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 Canada-based sponsors and CROs.
Questions about EDC for Canada
Does Elysium support Health Canada-regulated trials?
Yes. The platform is built for the record-keeping and data-integrity standards behind Division 5 No Objection Letters: audit trails on every field change, electronic signatures and exportable records. Health Canada approval is issued for your trial; Elysium provides the system foundation.
How does Elysium handle provincial privacy rules?
Because Elysium is processor-as-instructed, you stay in control of data placement of your documents and access settings. RBAC, encryption and access logging give you the controls PHIPA, PIPA and PIPEDA all call for. We recommend confirming your data handling with your institutional privacy office.
Can we build forms in both French and English?
Yes. All labels, instructions and content are custom text, so a study can carry French and English versions side by side — useful for multi-province studies and consent workflows.
Do we need dedicated IT to run Elysium?
No. It is fully web-based. Coordinators, CRAs and data managers each get their own login; no software is installed at Canadian sites, which suits sites with restricted IT environments.
What are the Canadian dollar prices?
This page shows CAD-equivalent figures for budgeting. Subscriptions are billed in US dollars with itemised invoices; see the pricing section for the current CAD numbers.
Elysium EDC in other regions
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