Clinical research & efficacy validation

Clinical research and efficacy validation are essential components in establishing the scientific credibility, safety profile, and functional value of dietary supplements. At the Academy of Medical Sciences, Vietnam (AMS Vietnam), clinical research is conducted with the objective of generating high-quality evidence that substantiates health benefits, supports regulatory compliance, and builds trust among consumers, healthcare professionals, and authorities.

AMS Vietnam provides comprehensive clinical research services for dietary supplements, grounded in rigorous scientific methodology, ethical governance, and alignment with national and international standards. Our work bridges laboratory research, formulation science, and real-world human outcomes—ensuring that claimed benefits are supported by credible clinical data.

Dietary supplements are increasingly used to support health, prevent deficiencies, and improve quality of life. However, without properly designed clinical research, claims regarding efficacy remain speculative and vulnerable to regulatory, scientific, and market scrutiny.

Clinical research at AMS Vietnam serves to:

• Demonstrate measurable health benefits in human subjects
• Validate functional claims with objective outcomes
• Assess safety and tolerability in intended populations
• Support product differentiation through scientific evidence
• Provide documentation for regulatory submission and market authorization

By applying clinical research principles traditionally used in pharmaceutical development—adapted appropriately for dietary supplements—AMS Vietnam ensures that evidence is robust, transparent, and fit for purpose.

The Academy of Medical Sciences, Vietnam offers end-to-end clinical research services tailored to dietary supplement development, from early human studies to post-market evidence generation.

Efficacy Evaluation

AMS Vietnam designs and conducts clinical studies to evaluate the efficacy of dietary supplements in supporting specific health outcomes, such as:

• Metabolic health and weight management
• Digestive and gut health
• Immune function support
• Cardiovascular health
• Cognitive performance and mental well-being
• Musculoskeletal health
• Skin, hair, and aging-related outcomes

Efficacy endpoints are selected based on scientific plausibility, regulatory relevance, and the intended use of the product.

Safety and Tolerability Assessment

While dietary supplements are generally considered low risk, safety assessment in human use remains essential. Clinical studies conducted at AMS Vietnam evaluate:

• Adverse events and tolerability
• Short- and medium-term safety outcomes
• Interaction with diet, lifestyle, or concurrent supplement use

Safety monitoring follows standardized clinical protocols and ethical oversight procedures.

AMS Vietnam applies internationally recognized clinical research methodologies, adapted to the regulatory and scientific context of dietary supplements.

Study Designs

Depending on the research objective, AMS Vietnam conducts:

• Randomized controlled trials (RCTs)
• Double-blind or single-blind studies
• Placebo-controlled studies
• Open-label observational studies
• Pilot and feasibility studies

Study design selection is driven by the level of evidence required, feasibility considerations, and regulatory expectations.

Population Selection

Clinical studies are conducted in carefully defined populations, including:

• Healthy adults
• Specific age groups (children, adults, elderly)
• Populations with defined functional conditions (e.g., digestive discomfort, fatigue, metabolic imbalance)

Inclusion and exclusion criteria are established to ensure data validity and participant safety.

Outcome Measures

AMS Vietnam employs validated and objective outcome measures, including:

• Clinical biomarkers
• Functional performance indicators
• Anthropometric measurements
• Laboratory parameters
• Standardized questionnaires and patient-reported outcomes

Data collection methods are selected to minimize bias and maximize reproducibility.

All clinical research conducted by the Academy of Medical Sciences, Vietnam adheres to strict ethical and regulatory standards.

Ethical Review and Participant Protection

• All studies undergo independent ethical review and approval
• Informed consent is obtained from all participants
• Participant confidentiality and data protection are ensured
• Studies comply with principles of the Declaration of Helsinki and Good Clinical Practice (GCP), as applicable

Regulatory Alignment

Clinical research for dietary supplements is designed to align with:

• Vietnamese regulations governing food and dietary supplements
• International guidance on health claims and functional foods
• Requirements for product registration, marketing authorization, and claim substantiation

AMS Vietnam supports clients and partners in preparing scientific dossiers and documentation based on clinical study outcomes.

Scientific integrity and transparency are central to AMS Vietnam’s clinical research activities.

Data Management

• Standardized data collection and monitoring procedures
• Secure data storage and quality control systems
• Traceability and audit readiness

Statistical Analysis

• Predefined statistical analysis plans
• Appropriate sample size calculation and power analysis
• Use of validated statistical methods

Reporting and Documentation

AMS Vietnam delivers comprehensive clinical study reports, including:

• Study protocol and methodology
• Statistical analysis results
• Safety and efficacy conclusions
• Limitations and interpretation

Reports are suitable for regulatory submission, internal R&D decision-making, and scientific publication.

Clinical research at AMS Vietnam is closely integrated with dietary supplement research and development activities. Clinical findings are used to:

• Optimize formulations and dosing strategies
• Refine product positioning and intended use
• Support innovation pipelines with human evidence
• Guide future research and product line expansion

This integrated approach ensures that clinical research is not conducted in isolation, but as part of a coherent product development strategy.

AMS Vietnam collaborates with:

• Dietary supplement manufacturers
• R&D organizations
• Healthcare institutions
• Universities and research centers

Partnership models are flexible and may include contract research, joint studies, or co-development arrangements. All collaborations are governed by clear scientific, ethical, and confidentiality frameworks.

Where appropriate, clinical research outcomes contribute to broader scientific knowledge through:

• Peer-reviewed publications
• Scientific conferences and symposia
• Technical reports and policy-relevant briefs

AMS Vietnam promotes responsible dissemination of results, ensuring accuracy and avoiding overstatement of claims.

In an increasingly competitive and regulated dietary supplement market, scientific credibility is a critical asset. The Academy of Medical Sciences, Vietnam is committed to delivering clinical research that withstands scientific scrutiny, supports responsible innovation, and protects public health.

Through rigorous clinical research and efficacy validation, AMS Vietnam helps ensure that dietary supplements are supported by evidence—not assumption—and that health claims are grounded in sound science.