EDC Software for Clinical Trials in Hong Kong
Department of Health and REC-ready EDC for Hong Kong research sites
Hong Kong punches far above its size in clinical research. Run clean, PDPO-conscious eCRF data across your sites with Elysium — priced transparently in Hong Kong dollars.
- Compliant audit trails & e-signatures
- Local-currency pricing: HK$8 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
Hong Kong is one of the busiest clinical research hubs in Asia Pacific, with prestigious academic medical centres, a deep pool of oncology and rare-disease trials, and a regulatory process that international sponsors find predictable. The Department of Health (DH) Pharmacy and Poisons Board grants clinical trial certificates, while each institution’s Research Ethics Committee (REC) reviews protocols before any participant is enrolled.
What consistently separates fast, inspection-ready studies in Hong Kong from slow ones is the quality of the data infrastructure. Elysium Clinical Trials EDC gives research teams an electronic case report form platform that matches both the pace of HK trial start-up and the strictness of its data-integrity culture.
This page covers how Elysium aligns with Hong Kong’s regulatory expectations and the Personal Data (Privacy) Ordinance, and what it costs in local dollars.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in Hong Kong.
Department of Health (Pharmacy and Poisons Board)
Issues the clinical trial certificate required for trials conducted in Hong Kong. Elysium’s clean audit trail and exportable records support the data requirements that accompany the certificate.
Research Ethics Committees (REC)
Institutional RECs review and monitor clinical trials at each site. Solid documentation, versioned eCRFs and complete records make REC progress reviews straightforward.
Hong Kong Clinical Trials Registry (HKCTR)
The public registry that promotes transparency around HK trials. Clean, exportable data helps you keep registry records accurate.
Personal Data (Privacy) Ordinance (PDPO)
Hong Kong’s data protection law (enforced by the PCPD). Role-based access, encryption and access logging help you comply with the six data protection principles.
Hong Kong trials sit at the intersection of a British-influenced governance framework and mainland-Greater-Bay-Area expansion. Sponsors frequently use HK sites as anchors for Greater Bay Area and APAC studies. Elysium supports that structure: one study, multiple sites, site-level data delegation and a single audit trail across the whole region.
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 Hong Kong actually work
- Standalone deployment model for HK teams that prefer keeping data in their own infrastructure context
- English and Chinese-capable forms for bilingual sites and consent processes
- DELO-style editing: field-level audit with no silent overwrites
- Multi-site and multi-language support ready for Greater Bay Area roll-outs
- Electronic signatures aligned to the record-keeping expectations of HK auditors
- Exports to CDISC ODM and Excel for your data management team
Hong Kong research groups are expected to deliver international-quality data on international timelines. Elysium removes the friction of paper, spreadsheets and outdated legacy EDC — giving HK sites and the global sponsors working with them a modern, compliant and affordable platform.
Pricing for Hong Kong in Hong Kong 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 Hong Kong-based sponsors and CROs.
Questions about EDC for Hong Kong
Is Elysium compliant with Hong Kong’s clinical trial regulations?
Elysium aligns with the record-keeping and data-integrity expectations behind DH clinical trial certificates and REC reviews. The certificates and approvals themselves are issued by the Hong Kong authorities for your specific study, and Elysium provides the system foundation they expect to see.
How does Elysium help with PDPO compliance?
Access is controlled by role and permission, data is encrypted, and every access and change is logged. As a processor we act only on your instructions, and you decide retention and deletion windows in the system.
Can we use Elysium for a multi-centre HK study with one lead site?
Yes. Create the study once, add each participating site, and control exactly what data each site can see and edit. The lead site and central data manager keep full visibility.
Do you support traditional Chinese content?
Form labels and content are fully customisable text, so you can write them in English, traditional Chinese, or both within the same study.
What are the HK dollar prices?
Prices on this page are shown in Hong Kong dollars as a budgeting guide. Your subscription is billed in US dollars with an invoice for each charge; see the pricing section for current HKD-equivalent figures.
Elysium EDC in other regions
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