Location · SingaporeUpdated September 28, 2026

Clinical trial software for studies in Singapore

Singapore is often the first Asia-Pacific site in a global trial: efficient regulators, experienced hospitals and English-language operations. Capture runs Singapore sites in the same study as the rest of the world, with the controls HSA inspectors expect.

  • One study across regions
  • Part 11-aligned controls
  • No per-site fee

Free sandbox · No credit card · 21 CFR Part 11 aligned

Study settings · Region
SG

Study region

Singapore

Regulator
Health Sciences Authority (HSA)
Ethics
Institutional review boards
Data protection
Personal Data Protection Act (PDPA)
Hosting options
EU (Frankfurt) or US (N. Virginia)
Language
English operations
AES-256 at rest TLS in transit Chosen at study setup

Key points for studies in Singapore

  • Clinical trials of therapeutic products are regulated by the Health Sciences Authority (HSA), with routes such as clinical trial authorisation, notification or certificate depending on the product and risk.
  • Studies also need approval from the relevant institutional review board; the large public healthcare clusters run their own central review boards.
  • Personal data is governed by the Personal Data Protection Act (PDPA), which restricts transfers overseas unless the recipient provides comparable protection. Research involving human biological material may also fall under the Human Biomedical Research Act.
  • English is the working language of research in Singapore, which simplifies site training and document management.
  • Singapore is frequently used as a regional hub, activating early in multinational studies alongside sites in other Asia-Pacific countries.

Research landscape

Why global trials often start their Asia-Pacific arm in Singapore

Singapore combines a compact, well-organised healthcare system with regulators and review boards that are used to international trials. For sponsors, that means predictable start-up and sites comfortable with global SOPs. For academic groups, it means strong national research funding and clinical trial networks across the public healthcare clusters.

From a data point of view, a Singapore site in a global trial should work exactly like every other site: the same locked forms, the same edit checks, the same randomisation and one audit trail. Local differences belong in configuration (site numbering, site-specific consent versions), not in a separate build.

The PDPA and overseas transfers

The PDPA's transfer limitation obligation requires organisations transferring personal data outside Singapore to ensure the recipient provides a comparable standard of protection, typically through contractual clauses. Research datasets in Capture use coded participant IDs for sponsor-side users, with identities visible only to site staff, which reduces what leaves the site in identifiable form. Document the hosting region and transfer basis in your study's data protection assessment.

Phase 3 · Study overview by site

Randomized

166 / 240

Open queries

24

Fields verified

84%

Site 01 · Boston48/60

3 open queries · 92% SDV

Active
Site 02 · Madrid41/60

7 open queries · 85% SDV

Active
Site 03 · Riga22/60

14 open queries · 61% SDV

At risk
Site 04 · Toronto55/60

0 open queries · 100% SDV

Frozen

Site risk

Site 03 query backlog

Data lock

Site 04 ready to lock

Controls

The same controls at every site, Singapore included

Every site runs with an append-only, hash-chained audit trail, re-authenticated electronic signatures with a stated meaning, role-based access with site-level separation and server-set timestamps. Approved forms are locked and identical across countries.

  • One field-level audit trail for the whole study.
  • Site coordinators see only their own site.
  • Blank eCRF PDFs for review board submissions.
21 CFR Part 11 compliant EDC

Weight changed 68.0 to 68.5 kg

Site coordinator · Reason: Transcription error

9f2c…a71e

Query Q-0014 answered on Weight

Site coordinator · Reason: Source checked

4b8d…c203

Vital signs form locked

Data manager · Reason: Visit cleaned

e61a…58f0
Verify chain Intact

Add a Singapore site to a sample study

Invite a coordinator, generate a site QR code and test enrolment in the free sandbox.

Build your study free

Before you start

Singapore study set-up checklist

HSA route confirmed

Authorisation, notification or certificate, depending on product and risk.

Review board approval

From the institution's or cluster's review board.

PDPA assessment

Hosting region and overseas transfer basis documented.

Biomedical research rules checked

Whether the Human Biomedical Research Act applies to samples or data.

Site activated

Ethics approval, contract, initiation visit and delegation log.

Consent version per site

Local consent versions approved and tracked.

Regional hub

Roles often based in Singapore, and what each needs from the system

RoleTypical scopeWhat they need in the study
Regional clinical research associateSites in several Asia-Pacific countriesAccess to assigned sites only, SDV per field, query lists by site.
Regional data managerData cleaning across the regionOpen query overview, edit check results, exports without identifying data.
Medical monitorSafety review for the regionRouted safety alerts, AE listings, SAE sign-off status.
Site coordinatorOne Singapore hospitalTheir own participants, visit schedule, eConsent and data entry.
Principal investigatorSite oversightSigning forms and SAEs, reviewing the delegation log.

Access in Capture is role-based with site-level separation, so a regional role can cover several sites without seeing others.

Operations

Running a hub across time zones and borders

A Singapore-based team working with sites in Australia, Korea, Japan, Taiwan and India covers several time zones and several data protection laws. What keeps the region consistent is one study build: identical forms, identical edit checks and a single definition of each endpoint, with country differences handled through site configuration and approved local consent versions.

Server-set timestamps matter more than usual in a multi-timezone region, because they show when each entry was actually saved, independent of the device clock. And because regional monitors review data remotely, a status overview of every subject and visit, plus a site risk monitor that explains why a site is flagged, is often more useful than waiting for the next on-site visit. See risk-based monitoring and SDV software.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Who regulates clinical trials in Singapore?

The Health Sciences Authority (HSA) regulates clinical trials of therapeutic products and medical devices.

Does the PDPA allow study data to be hosted outside Singapore?

Yes, if the recipient provides comparable protection, usually ensured by contract. Document the basis in your data protection assessment.

Can a Singapore site join a global study in Capture?

Yes. Every site runs in the same study with the same forms, checks and audit trail.

Where is data hosted for studies in Singapore?

Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Assess the cross-border transfer rules that apply to your study before choosing.

Can I try it before committing?

Yes. The free sandbox has every feature with no credit card and no time limit.

Run Singapore like every other site

One study, one audit trail, no per-site fee. Free sandbox.

Build your study free