EDC Software for Clinical Trials in the USA
FDA 21 CFR Part 11 compliant EDC built for American clinical research
Run eCRFs, manage subjects, and capture audit-ready data across your US sites — with electronic signatures, full audit trails, and validation support your inspectors actually look for.
- Compliant audit trails & e-signatures
- Local-currency pricing: $1 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
American clinical teams are judged on two things: the quality of their data and the integrity of their records. Sponsors, CROs, academic medical centers and site networks across all fifty states use Elysium Clinical Trials EDC to collect case report form data in a way that stands up to FDA inspections and 21 CFR Part 11 scrutiny.
Unlike heavyweight platforms that take months to deploy and cost six figures before data entry begins, Elysium gives your monitors, data managers and coordinators a fast, modern eCRF workspace from day one. You build study forms without writing code, lock databases when they are clean, sign off electronically, and export directly to SAS, Excel or CDISC ODM whenever your statistical team needs it.
This page explains how Elysium EDC maps to the specific regulations, guidance and expectations that govern clinical research in the United States — and what it costs in US dollars, in plain terms.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in United States of America.
FDA 21 CFR Part 11
Electronic records and electronic signatures: secure user access, audit trails, device checks, system validation, and e-signatures that are legally equivalent to hand-written initials in the eyes of the FDA.
ICH GCP E6(R2)
Aligned workflows for source data, query management, monitoring and protocol compliance so your site operations follow the international standard sponsors expect.
HIPAA / HHS 45 CFR 46
Role-based access, encryption and access logging help you protect protected health information and satisfy both the Privacy Rule and the Common Rule requirements for research records.
FDA Data Integrity (ALCOA+)
Attributable, legible, contemporaneous, original and accurate data capture by design, with edit checks and query trails that support clean, defensible datasets.
The FDA expects sponsors and sites to use systems that were designed for Part 11 from the ground up, not patched afterwards. Elysium ships with configurable user roles and privileges, automated audit logs on every field, and white-paper documentation you can adapt for your validation binder and 483/inspection-readiness package.
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 United States of America actually work
- Deploy eCRFs and go live in days instead of months — no dedicated IT build required
- Unlimited data-entry environments for testing, training and production under one account
- Electronic signatures at the form, visit and study level with full historical linkage
- Query and source-data-verification workflows that mirrors your monitoring SOPs
- Located data ownership with role-based delegation for CROs managing sponsor studies
- CSV, Excel, JSON and CDISC ODM export for your clinical data management pipeline
Whether you are a site running a single investigator-initiated trial or a CRO running fifty studies at once, the value is the same: a compliant, low-cost eCRF environment your team will actually enjoy using. Because Elysium is cloud-hosted, monitors and CRAs can review data from anywhere, and coordinators keep the same URL from study start to database lock.
Pricing for United States of America in US 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 United States of America-based sponsors and CROs.
Questions about EDC for United States of America
Is Elysium EDC 21 CFR Part 11 compliant?
Elysium is designed for Part 11 compliance: unique usernames and configurable roles, password rules, complete audit trails on every field, secure electronic signatures, and a documented validation framework. Your organization remains responsible for standard operating procedures, training, and your own validation checklist, and the platform is built to support that work.
Can CROs use Elysium to manage sponsor studies?
Yes. Each client organization gets isolated, role-based workspaces, so a CRO can give sponsors or monitors limited visibility while data managers retain full control. This multi-tenant model reads naturally as a sponsor-controlled environment during inspection.
How does Elysium handle PHI and HIPAA?
Access is controlled by role and permission at the study, form and field level, traffic is encrypted in transit, and data is encrypted at rest. We sign business associate agreements and recommend you mark only pseudonymized identifiers in the system, mirroring how most US sponsors already run their eCRF.
Does it integrate with SAS, R or CDISC?
Yes. Export study data to CSV, Excel, JSON or CDISC ODM, and use our REST API to feed downstream pipelines. Many US teams pipe Elysium exports directly into their SAS or R analysis datasets.
What does FDA inspection readiness look like?
Every field change, signature, query and edit is time-stamped and attributed to a named user. Records cannot be overwritten silently. You can reconstruct the entire study history from the audit trail, which is the core expectation of a 21 CFR Part 11 inspection.
Elysium EDC in other regions
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