ASEAN has no single trial approval. A regional study meets a different regulator, ethics structure, language and import system in every country, and they move at different speeds. Capture keeps all of them in one study, so you can add countries in waves as each one clears.
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Study region
Southeast Asia
Key points for regional studies in Southeast Asia
Strategy
The practical question for a Southeast Asian programme is the order in which countries open. A common pattern is to start where the regulator and the ethics committee are most predictable, use the experience to finalise the protocol and forms, and add slower countries behind. Singapore and Malaysia are often first; Thailand and the Philippines follow; Vietnam and Indonesia come last because of layered reviews and import logistics. Your own product, indication and sponsor relationships may change this order entirely.
A data system that supports waves needs to let you build the full protocol once, activate sites one at a time and keep forms identical across countries even as amendments arrive. In Capture, approved forms are locked for live use, new sites are created when they are cleared, participants are numbered by site, and sponsor users filter dashboards and exports by site. See multi-site clinical trial management and international multi-site trials.
Month
Opens first
At a glance
A starting map for planning conversations. Rows marked as general were not verified in detail. Confirm every row with the national authority and an ethics committee.
| Country | Regulator | Ethics | Dedicated guide |
|---|---|---|---|
| Singapore | HSA (authorisation or notification route by risk) | Institutional review boards | Singapore page on this site |
| Malaysia | NPRA (CTIL / CTX) | Favourable opinion before NPRA approval; NMRR registration | Malaysia page on this site |
| Thailand | Thai FDA (drug importation approval) | FDA-recognised ethics committee | Thailand page on this site |
| Philippines | FDA Philippines (general) | Institutional ethics boards (general) | Not covered separately |
| Vietnam | Ministry of Health (general) | Multiple ethics layers reported | Not covered separately |
| Indonesia | BPOM (general) | Institutional ethics boards reported to drive timelines | Not covered separately |
General summary, not legal advice. Philippines, Vietnam and Indonesia rows are generic and were not verified.
Create the forms and test your checks in the free sandbox, then add country sites as approvals arrive.
Data protection
Southeast Asian countries have different data protection laws, from long-standing frameworks in Singapore, Malaysia and Thailand to newer or developing regimes elsewhere. Most have rules on sending personal data abroad, and Capture hosts in the EU or the USA, so every country in your programme involves a transfer. Rather than writing six plans, build one operating model: identifying data stays at the site, sponsor-side users see coded IDs, the hosting region and transfer basis are written into contracts and consent text, and each country adds its specific requirements on top. Capture separates roles this way: site coordinators see participant names, researchers see coded IDs, enforced by row-level security at the database layer. Data is encrypted with AES-256 at rest and in transit with TLS.
Country notes live in the dedicated pages: Malaysia covers the amended PDPA and NPRA, Thailand covers the Thai FDA and PDPA, and Singapore covers HSA and local ethics boards. For how GDPR-style principles compare, see GDPR compliant clinical trial software.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Sites and connectivity
Capture runs in a browser and needs a connection to save data. It has no offline mode. Major hospitals in Singapore, Kuala Lumpur or Bangkok rarely have a problem, but provincial and island sites in the Philippines, Indonesia or Vietnam may. Decide per site how source is captured at the visit (paper or the clinic record) and who enters it into Capture afterwards. Participants complete questionnaires in a phone browser through a link, with no app to install, and sites can enrol participants with a QR code.
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Who uses it
Run several small studies without a platform contract per sponsor.
Read more AcademicInvestigator-led studies where one team builds forms, runs data entry and exports.
Read more APACAdd Southeast Asian countries to a Japan, Korea, Australia or India programme without a second system.
Read more Self-serveSelf-serve set-up with no service contract. Sponsor duties and submissions remain yours.
Read moreBefore you start
Which country opens first, and what drives the timeline in each.
Consent, participant information and questionnaire text per country; instrument licences held in your study file.
Investigational product import timelines for each country.
Institutional or national committee; amendments tracked as versions.
Legal basis, transfer basis and pseudonymisation documented.
Paper source plus delayed entry where needed.
Export once, reuse in each national ethics package.
No. Each country has its own regulator and ethics process. Harmonisation efforts exist, but trial approval remains country-specific. Confirm current rules with each authority.
It depends on your product and sponsor. Industry guides describe Singapore and Malaysia as faster and more predictable, with Vietnam and Indonesia usually slower because of layered reviews, translation and import. Your regulatory lead should decide.
Yes. One study can hold sites in many countries with site-level participant numbering, a separate site coordinator portal and exports filtered by site.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Document the transfer basis for each country in your contracts and consent text.
No. Capture is web based and needs a connection to enter data. Plan how remote sites capture source records and enter them later.
Participant-facing text is whatever your approved materials say. If you need to understand how a study will handle several languages, talk to us before you commit.
Not to use Capture. The platform is self-serve. You still carry sponsor obligations and the country submissions.
Yes. The sandbox has every feature with no credit card and no time limit. You pay only once you go live with real participants.
Keep exploring
Clinical trial software in Malaysia
NPRA, CTIL and the amended PDPA.
Clinical trial software in Thailand
Thai FDA and the PDPA.
Clinical trial software in Singapore
HSA and ethics boards.
Clinical trial software in India
Another large Asian market.
Clinical trial software in Japan
North Asia neighbour.
International multi-site trials
Running sites across countries.
Clinical trial software for regional CROs
Many small studies.
Same forms, site-level access, one audit trail. Free sandbox.