EDC Software for Clinical Trials in Saudi Arabia
SFDA-aligned EDC for the Kingdom’s rapidly expanding clinical research sector
Saudi Arabia is investing heavily in clinical trials under Vision 2030. Capture SFDA-ready eCRF data with Elysium — priced transparently in Saudi riyals.
- Compliant audit trails & e-signatures
- Local-currency pricing: SAR 4 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
Saudi Arabia is scaling its clinical research capacity at a remarkable pace, with the Saudi Food and Drug Authority (SFDA) modernising trial approvals, the Ministry of Health expanding research infrastructure, and national strategies actively attracting international phase II and III studies. The National Committee of Bioethics (NCBE) oversees ethics reviews through regional research ethics committees (RCBs), and the Kingdom has also enacted a modern Personal Data Protection Law (PDPL) with strict rules around consent and cross-border transfers.
For global sponsors and local CROs, Saudi studies offer strong enrolment and a strategic gateway to the Gulf. What they demand in return is data that passes international scrutiny. Elysium Clinical Trials EDC gives Saudi sites the eCRF infrastructure that establishes that confidence.
This page explains how Elysium aligns with the Saudi regulatory environment and what the platform costs in riyals.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in Saudi Arabia.
SFDA (Saudi Food and Drug Authority)
SFDA oversees and approves clinical trials in the Kingdom, including oversight of investigational products. Elysium supports the data-integrity and record-keeping expectations of SFDA-approved studies.
MOH & National Committee of Bioethics (NCBE)
The Ministry of Health oversees the research sector while NCBE and regional RCBs provide ethical review. Clean, versioned records make ethical review and continuing reports straightforward.
PDPL & NDMO (Personal Data Protection Law 2023)
Saudi Arabia’s privacy law sets rules for consent and cross-border data transfers. Elysium supports local data administration via RBAC and provides access logging to support PDPL obligations.
ICH GCP E6(R2)
International sponsors expect the ICH GCP standard; Elysium aligns query, SDV and monitoring workflows to it for every participating site.
Saudi trials commonly involve an international sponsor, a local CRO and one or more Saudi sites, with approvals coordinated through SFDA and the relevant RCB. Elysium mirrors that structure naturally: a single study environment containing Saudi and international sites, site-level data delegation and one audit trail that satisfies both SFDA inspection expectations and the sponsor’s global quality standards.
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 Saudi Arabia actually work
- Study environments ready for international phase II/III programmes anchored in Saudi Arabia
- Arabic and English forms to suit bilingual site teams and participants
- Fast CRF build-up so SFDA submissions stay aligned with operational readiness
- Remote monitoring support for sponsors and CROs across time zones
- Multi-site structure for expanding across Riyadh, Jeddah, Dammam and beyond
- SAR-priced plans that make Kingdom budgeting and procurement clear
Saudi Arabia is actively competing for global trials, and its sites are investing to win them. Elysium gives sponsors, CROs and Saudi hospitals a compliant, modern eCRF platform that signals readiness immediately — data is trustworthy from the first subject, and the audit trail tells the story any inspector would want to hear.
Pricing for Saudi Arabia in Saudi Riyal
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 Saudi Arabia-based sponsors and CROs.
Questions about EDC for Saudi Arabia
Does Elysium align with SFDA trial approvals?
Elysium provides the data-capture and record foundation SFDA oversight depends on — audit trails, electronic signatures, versioned forms and full exporting. Approval itself is granted by SFDA; Elysium supports the system expectations those approvals carry.
How does Elysium help us meet PDPL requirements?
Elysium processes data only under your instructions, with role-based access, encryption and complete access logging. Consent, international transfer and retention decisions remain yours; we support documenting the technical controls in your PDPL assessments.
Do you support Arabic forms?
Yes. All labels and content are custom text, so a study can carry English, Arabic, or both. This fits Saudi sites where staff may be bilingual and ICFs are often prepared in both languages.
Can Saudi and international sites run one trial together?
Yes. Add Saudi and non-Saudi sites under the same study and delegate access per site. The sponsor and central data manager retain full visibility, and remote monitors can review from anywhere.
What are the riyal prices?
This page shows SAR-equivalent figures for budgeting based on the current exchange rate. Subscriptions are billed in US dollars with itemised invoices; see the pricing section for current SAR numbers.
Elysium EDC in other regions
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