EDC Software for Clinical Trials in the United Kingdom
MHRA-ready EDC for UK sites, CROs and NHS-linked research
Collect high-quality data across your UK trial sites with an eCRF system aligned to MHRA expectations, UK GDPR and ICH GCP — plus transparent pricing in British Pounds.
- Compliant audit trails & e-signatures
- Local-currency pricing: £1 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
The UK remains one of the most research-active markets in the world, and the post-Brexit regulatory landscape has made it simpler than ever to run single and multi-site trials under Medicines and Healthcare products Regulatory Agency (MHRA) rules. The catch is that Health Research Authority processes, UK GDPR obligations and strict GCP expectations leave little room for outdated data systems.
Elysium Clinical Trials EDC was built for exactly this environment. Investigators can build electronic case report forms in hours, coordinators can capture data that satisfies the ALCOA+ standard, and sponsors can monitor, lock and sign off databases without shipping paper to anyone. Everything is UK-GDPR conscious by default, with role-based access, granular audit trails and full data export.
This page sets out how Elysium fits UK research workflows, which authorities matter for your study, and what pricing looks like in sterling.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in United Kingdom.
MHRA
Medicines and Healthcare products Regulatory Agency is the UK competent authority that reviews and oversees clinical trials of investigational medicinal products. Elysium supports the documentation and data-integrity expectations of MHRA GCP inspections.
Health Research Authority (HRA)
The HRA streamlines national ethics and regulatory approvals through IRAS and the approvals workstream. Clean, exportable data simplifies the record requirements and safety reporting obligations managed under HRA oversight.
UK GDPR & Data Protection Act 2018
Lawful basis, processor agreements, retention controls and rights-enabled workflows are designed in. We act as a processor under your instructions through a data processing agreement.
ICH GCP E6(R2)
Query management, source data verification, deviations and monitoring features align Elysium to the international standard British sponsors and NHS trusts cite in their trial agreements.
For trials conducted in NHS settings, the HRA approval and a favourable Research Ethics Committee opinion must be in place before any participant is enrolled. Elysium does not replace governance approvals — it makes the data side of those approvals manageable, including the monitoring visits, query resolution and database-lock documentation that MHRA inspectors routinely examine.
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 Kingdom actually work
- Study setup for UK single-centre or multi-site trials without dedicated IT
- Compliant electronic signatures and audit trails that remove the need for wet-ink corrections
- Query and SDV workflows that let CRAs work remotely across sites
- GDPR-aligned user access with configurable roles and immediate account deactivation
- CSV, Excel, JSON and CDISC ODM exports for your ODM-to-statistics pipeline
- UK-friendly support hours with rapid onboarding for coordinators and monitors
British research groups face the same pressure as their US counterparts: more studies, tighter timelines and thinner budgets. Elysium gives NHS trusts, academic groups and commercial CROs a cost-effective eCRF platform that starts in days, scales to thousands of subjects, and keeps your records in the shape an inspector would ask for.
Pricing for United Kingdom in British Pound
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 Kingdom-based sponsors and CROs.
Questions about EDC for United Kingdom
Is Elysium compliant with MHRA expectations?
Elysium is built around the pillars of GCP and ALCOA+ that MHRA inspectors check: attributable, contemporaneous and original records, complete audit trails, electronic signatures and validated system documentation. It supports your MHRA compliance rather than substituting for the governance approvals themselves.
How does Elysium help us satisfy UK GDPR?
Elysium processes personal data only on your documented instructions, under a data processing agreement. You control who sees what at study, form or field level; you can export or redact data, and access can be revoked instantly. You remain the controller and decide retention periods.
Can we run a study with sites across multiple NHS trusts?
Yes. You create one study environment, add each site, assign site-specific users and delegate data access by role. Monitors can filter by site, and every record keeps a clean audit trail for the whole trial.
Do you invoice in British Pounds?
Prices on this page are shown in GBP as a local indication. Final billing is in US dollars on the subscription plan you choose, and we issue an invoice you can raise against. See the pricing section below for current sterling-equivalent numbers.
What word do we use for a study in British English?
Trial. Elysium uses both "study" and "trial" throughout so UK teams feel at home, and you can rename labels in the system to match your own terminology.
Elysium EDC in other regions
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