in the Philippines
Phase of Your Trial
Advancing Trials Together
Welcome to Harmony Trials, a Contract Research Organization (CRO) providing expert-driven clinical research services in the Philippines – a leading destination for clinical trials in Southeast Asia. Harmony Trials delivers comprehensive support for Phase IB to IV clinical trials, including regulatory, monitoring, and site management services.
Our leadership team and key clinical research professionals bring over 20 years of industry experience, having collectively supported more than 100 clinical trials involving over 80,000 participants across various therapeutic areas such as infectious diseases, oncology, pulmonology, rheumatology, and vaccines. Harmony Trials is committed to advancing trials throughout the Philippines.
Harmony Trials is registered with the Securities & Exchange Commission with a registration number of 2024110176259-04, and the Philippine Food & Drug Administration with a CRO License to Operate of CDRR-NCR-CRO-1308490.
Why Choose the Philippines?
- Globally Ranked Hospitals: Included in the Newsweek World’s Best Hospitals 2026 evaluation, 33 local institutions were globally recognized, including 2 hospitals breaking into the Top 250 World’s Best Hospitals.
- Expanding Market: Total Health Expenditure reached $25.35 billion USD (PHP 1.56 trillion, making up 5.9% of the GDP), marking a 17.1% year-on-year increase.
- Massive English-Fluent Workforce: The local clinical system is powered by over 248,500 healthcare workers nationwide. The vast majority of these professionals are fully fluent and proficient in English.
- English Documentation: All regulatory submissions, clinical protocols, and medical data records are entirely drafted and processed in English.
- USFDA Validated: 19 inspections completed with 100% compliant NAI (No Actions Indicated) / VAI (Voluntary Actions Indicated) ratings.
Patient Demographics & Pediatric Study Potential
Total Country Population: 112,729,484 People
Pediatric Cohort (Aged 0–14):
- National total fertility rate of 1.9 children per woman
- Children represent roughly 27% of the total population
- A pool of 30.4 million children for pediatric and neonatal studies.
Total Country Population: 112,729,484 People Annual Newborns: 1,358,989 live births annually
Top Mortality Drivers
Ischaemic Heart Diseases
Neoplasms / Cancers
Cerebrovascular Diseases / Stroke
Pneumonia
Diabetes Mellitus
Track Record: Clinical Trials by Phase
According to data from ClinicalTrials.gov, the Philippines has participated in about 1,000 studies. The country excels in late-phase clinical development, with the majority of studies focused on Phase III:
Trial Phase
Number of Historical Studies
Phase I
37 studies
Phase II
240 studies
Phase III
758 studies
Phase IV 106 studies
106 studies
Regulatory, IRB & Timelines
Philippine Food & Drug Administration (PFDA): Applications are submitted electronically by licensed CROs or Sponsors. Review takes 60 days (from the time of review and excluding applicant clock-stops); rolling submissions are not accepted. The Philippine FDA issues 2 approvals: Clinical Trial Approval and Import License.
Institutional Review Boards (IRB): Submissions run parallel to the PFDA. Trials across multiple Department of Health hospitals utilize the Single Joint Review Ethics Board (SJREB) for review only, while final approval remains with individual institutional IRBs. IRB timelines range from 3 to 6 months.
Contracts: Agreement templates from the sponsor or CROare widely accepted since investigators act as independent contractors rather than permanent institutional employees
Total Startup Timeline: Expect an average of 5 months from review of the Clinical Trial Application Dossier of the PFDA and the first IRB.
References Used
Newsweek Rankings: Global healthcare institutional accreditation tiers and top hospital rankings.
Philippine Statistics Authority (PSA):
2024 Census of Population (POPCEN) – Official total population data.
- 2025 Causes of Death in the Philippines (Provisional release, mapping out the top mortality drivers).
- National Demographic and Health Survey (NDHS) (Fertility rate metrics).
Philippine FDA
Link: https://www.fda.gov.ph/
USFDA Inspections Database Filters Bioresearch Monitoring Drugs Device Biologics Date 14May2024
ClinicalTrials.gov Data
