Location · ThailandUpdated October 13, 2026

Clinical trial software for studies in Thailand

Thailand has no dedicated clinical trial law. Trials run on Thai FDA drug importation approval, an FDA-recognised ethics committee and the Personal Data Protection Act. Capture gives Thai sponsors and investigators a self-serve EDC they can build and test free.

  • Self-serve, no local IT
  • Audit trail and e-signatures
  • Free sandbox, pay at go-live
Build your Thai study freeBook a demo

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

Study settings · Region
TH

Study region

Thailand

Regulator
Thai FDA (importation of trial drugs)
Ethics
FDA-recognised ethics committee
Standard
ICH GCP, Drug Act B.E. 2510
Data protection
Personal Data Protection Act, PDPC
Hosting region
EU (Frankfurt) or US (N. Virginia)
AES-256 at rest TLS in transit Chosen at study setup

Key points for studies in Thailand

  • Thailand has no specific statute for clinical trials. Practice rests on the Drug Act B.E. 2510, Thai FDA notifications and international standards, in practice ICH GCP.
  • Under the Thai FDA's clinical trial notification, a trial may start only after approval by an ethics committee recognised by the FDA and FDA approval of the importation of the trial drugs. A separate importation notification, expected to take effect in March 2024, describes a clinical trial application to the FDA and a permit valid for five years. Confirm the final wording with the FDA.
  • Older sources say the FDA recognises a limited list of ethics committees (11 at the time). An ethics committee outside that list may require a separate FDA step, so check the current list.
  • Reporting duties reported in a 2016 notification include an annual progress report in October and a summary report within 60 days of completion. These are old sources. Verify the current deadlines.
  • The Personal Data Protection Act applies to trial data, and its treatment of scientific research is not settled in the secondary sources we found. Capture hosts in Frankfurt and N. Virginia, not in Thailand, and has no offline mode.

Regulation

Ethics first, then FDA importation approval

In Thailand the ethics committee review is the main gate, because the FDA looks at the committee's review when it assesses the application to import trial drugs. A committee recognised by the FDA gives its approval, the sponsor or investigator applies to the Thai FDA with the protocol and product and safety data, and the trial starts only when both are in place. Practitioner guides report Thailand as allowing parallel ethics and FDA submissions, and that FDA inspections can extend to studies conducted overseas.

Practical consequence: your package includes the protocol, consent forms, participant information in Thai and a description of what will be collected. Capture exports a blank eCRF PDF with a cover page, form index and visit-by-form matrix, and every approved form printed empty, which is a convenient attachment for the committee. Once the study is running, the audit trail, with timestamp, user, old value, new value and reason for change on every field, supports the committee's follow-up and any inspection. See audit trail software for clinical trials.

Observational, device and non-drug studies

Questionnaire, registry and many device studies do not involve drug importation. They still need ethics review, and the FDA may be consulted for devices. Ask the committee at the start which route your study follows.

Blank eCRF · no subject data

Visit by form matrix

FormSCRD1W2W4W8EOS
DemographicsX
Vital signsXXXXXX
LaboratoryXXX
ECGXX

3. Was the ECG performed?

☐ Yes☐ No

If No, complete question 4.

Protocol CAP-001 · v1.0Page 3 of 24

Data protection

The PDPA and trial data hosted abroad

Thailand's Personal Data Protection Act treats health data as sensitive and sets rules for lawful basis, consent, security and transfers abroad, supervised by the Personal Data Protection Committee. One 2024 analysis reads sections 24 and 26 as possibly allowing processing for scientific research without consent where appropriate safeguards are in place, and stresses pseudonymisation and encryption for sensitive data. It also calls the legal basis for trial data ambiguous. Treat that as a reading by one commentator, not as advice, and ask Thai counsel before you rely on any research exemption.

Capture hosts in the EU (Frankfurt) or the USA (N. Virginia), so Thai participant data is transferred abroad. Write the transfer basis into your data sharing agreement and the participant information. In Capture, site coordinators see participant names, researchers see coded IDs and row-level security enforces the split, with AES-256 at rest and TLS in transit. For a comparison with the best-known regimes, see HIPAA vs GDPR clinical trial data.

Site coordinator

Jane Peterson

DOB: 04-Mar-1978

Subject 01-004

Sees direct identifiers

Researcher

Subject 01-004

DOB: withheld

Coded ID only

Sees coded ID only

Same record, two roles. Row-level security enforces the split.

Test your Thai study before approvals land

Build the forms and sign a test consent in the free sandbox. Go live only when the committee and the FDA have cleared the study.

Build your Thai study free

Typical start-up

A start-up sequence for Thailand

A sketch for planning, not a regulatory timeline. Confirm every step with the Thai FDA and your ethics committee.

  1. 1

    Pick a recognised committee

    Confirm that the committee is on the FDA's current list, or ask what extra step applies if it is not.

  2. 2

    Prepare the package

    Protocol, investigator brochure, Thai consent and participant information, site details and the blank eCRF PDF from Capture.

  3. 3

    Apply in parallel where allowed

    Send the ethics and importation applications at the same time if the FDA and committee allow it.

  4. 4

    Import trial drugs after approval

    The FDA approves importation. Keep the permit and its validity dates in the study file.

  5. 5

    Open sites and report

    Create site accounts, train staff, enrol, and diarise annual and end-of-study reports with the FDA.

Thai research

Hospitals, universities and where a self-serve platform fits

Thailand has major university hospitals in Bangkok and other cities and is often used in Asia-Pacific programmes next to Malaysia and Singapore. Academic and investigator-initiated studies run alongside multinational trials. Teams without an enterprise EDC budget can use Capture with no setup fee and no per-site fee. See EDC for investigator-initiated trials and clinical trial software without a CRO.

For the regional picture, including countries with different ethics structures, read clinical trial software for Southeast Asia. If your programme also includes Malaysia, the NPRA licence route is described in clinical trial software in Malaysia.

Before you start

Thailand study set-up checklist

FDA-recognised committee confirmed

Check the current list, and ask what applies if your site's committee is not on it.

Importation application

Protocol, product and safety data, using the current Thai FDA notification.

Thai materials approved

Consent, participant information and questionnaire text; instrument licences held in your study file.

PDPA plan

Lawful basis, pseudonymisation and transfer basis for EU or US hosting, checked with Thai counsel.

Reporting calendar

Annual and end-of-study reports to the FDA, as the current notification requires.

Connectivity fallback

Paper source and delayed entry for sites that cannot rely on a connection.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Who regulates clinical trials in Thailand?

The Thai FDA approves the importation of trial drugs, and an ethics committee recognised by the FDA must approve the study. There is no specific clinical trial statute, so practice follows the Drug Act, FDA notifications and ICH GCP. Confirm the current process with the FDA.

Can ethics and FDA applications run at the same time?

Practitioner sources report that parallel submissions are possible in Thailand, but the trial can only start once both approvals are in place. Check with the FDA and your committee.

Which data protection law applies in Thailand?

The Personal Data Protection Act, supervised by the Personal Data Protection Committee. How it applies to scientific research is not settled in the sources we found, so ask Thai counsel.

Does Capture host data in Thailand?

No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Document the transfer basis in your contracts and participant information.

Does Capture work offline?

No. Capture is web based and needs a connection to enter data. Plan how sites capture source when connectivity fails.

Is Capture approved by the Thai FDA?

No regulator approves or certifies EDC software the way the FDA approves importation for a trial. Capture provides controls such as an audit trail and e-signatures; your validated use and submissions are what regulators assess.

Can I try it free?

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

Keep exploring

Related pages

Clinical trial software for Southeast Asia

The regional picture.

Clinical trial software in Malaysia

NPRA CTIL and CTX.

Clinical trial software in Singapore

HSA and ethics boards.

eConsent software

Verified electronic signatures.

Audit trail software

Evidence for committees and inspectors.

Clinical trial software without a CRO

Self-serve study set-up.

Build your Thai study yourself

Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.

Start freeBook a demo
Build your Thai study free