Trial Phase 1-4
Researchers and CROs usually approach trials through a sequence of phases; each fulfilling a distinct role in the evaluation of novel medical interventions, such as medications, therapies, or medical apparatus.
Phase 1:
Assessment of Safety and Tolerability
In the initial phase, the objective is to analyze the safety, appropriateness (i.e., dosage range), and possible adverse reactions of the intervention throughout the trials. Key considerations are ensuring safety and establishing optimal dosage amongst volunteers.
Phase 2:
Efficacy and Side Effects
The objective is to evaluate the efficacy of the intervention within a broader patient population with the targeted condition or disease. Key considerations are effectiveness, determining suitable dosage, and preliminary insight into side effects.
Phase 3:
Testing Efficacy in Large Groups of
Trial Participants
the objective is to validate the efficacy of the intervention, oversee adverse reactions, and juxtapose it with current treatments within a more expansive and varied patient demographic. Key considerations in this stage include reinforcing the efficacy and further validation of results, further assessment of potential side effects, and an overarching comparison with existing treatments.
Phase 4:
Monitoring Effectiveness in the General Population
In this last phase, Phase IV, the objective is to continuously observe the intervention in terms of safety and effectiveness. This is a precautionary practice prior to its approval and public release. Key considerations in this stage are the prolonged safety evaluation, infrequent adverse outcomes, and its assessment of real world efficacy.

Biometrics forms the backbone of every successful clinical trial—shaping how data is captured, managed, and interpreted. At Clinixir, we ensure that the data behind your study is not only accurate, but also compliant, reliable, and ready to support confident decision-making at every phase.
Our team provides full-service data management and biostatistics support across the clinical trial lifecycle. Patient data is handled using validated e-clinical systems that meet international standards, including US FDA 21 CFR Part 11. Each dataset is carefully curated to maintain consistency, traceability, and integrity—laying the groundwork for efficient monitoring and regulatory review.
We take a flexible yet structured approach to data management. Data collection processes are tailored to the needs of each study while being organized within standardized metadata frameworks, ensuring results can be compared, analyzed, and interpreted with clarity. This makes it easier for sponsors to draw meaningful insights—faster and with greater confidence.
From the outset, our biostatisticians collaborate with your team to develop statistical analysis plans that align with your protocol and reduce bias. Whether it’s designing endpoints, supporting interim analyses, or preparing final reports, we provide sound statistical expertise that strengthens your study’s scientific and regulatory credibility.
Biometrics at Clinixir is more than just data handling—it’s an essential function that underpins ethical, high-quality clinical research. Whether managing a local study in Thailand or supporting a multi-country study, we’re here to ensure your data stands up to scrutiny and drives the success of your trial.
Clinical Trial Management
Clinixir offers end-to-end clinical trial management solutions, providing sponsors with comprehensive support at every stage of the clinical research process—from study design and regulatory submission to compliance, pharmacovigilance,
site management, and data management.
Clinixir offers end-to-end clinical trial management solutions, providing sponsors with comprehensive support at every stage of the clinical research process—from study design and regulatory submission to compliance, pharmacovigilance, site management, and data management.
Our extensive expertise in clinical research, combined with strong partnerships with six leading medical institutions across Thailand, enables us to deliver high-quality data while ensuring full compliance with international regulatory standards.

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Efficient and data-driven feasibility assessments are essential to identifying potential challenges early and ensuring each clinical trial is strategically designed for success.
A leading cause of clinical trial delays is insufficient patient enrollment. To help mitigate this risk, Clinixir’s feasibility team engages directly with sponsors and sites—assessing investigator interest, patient availability, projected enrollment rates, and site capabilities. This insight enables smarter site selection, faster study start-up, and better-informed planning.
As part of our strategic feasibility services, we also collaborate with Key Opinion Leaders (KOLs) to provide early protocol insights and site recommendations. Their clinical expertise helps refine study design, ensure alignment with local practices, and strengthen investigator engagement from the outset.
Feasibility services are available as part of a full-service package or as a standalone, fee-based engagement. Investing in a professional feasibility study can significantly reduce trial risk, optimize resource allocation, and improve the likelihood of meeting enrollment targets.
Learn more about our KOL Consultation Service → -
Selecting the right sites is a critical factor in the success of any clinical trial. With Clinixir’s extensive network of clinical research centers across Thailand, we help sponsors identify and engage the most suitable sites based on protocol requirements, therapeutic focus, and target population.
Our site selection strategy enhances capacity and expertise, improves patient access, and ensures alignment with trial timelines. By leveraging relationships with top-performing hospitals, academic centers, and investigators, we enable sponsors to benefit from faster start-up, better enrollment, and cutting-edge clinical infrastructure.
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Clinixir facilitates the critical start-up phase of clinical trials in Thailand—laying the groundwork for smooth execution and regulatory compliance from day one.
Our dedicated Study Start-Up (SSU) team handles all activities related to site readiness and regulatory submissions, including preparation and coordination of essential documents for Thailand’s FDA, as well as central and local ethics committees (EC/IRB). We ensure that every step aligns with both national regulations and international Good Clinical Practice (GCP) standards.
Each study is assigned an experienced SSU specialist who works closely with investigators and site staff to streamline approvals, reduce delays, and maintain submission accuracy. Our strong familiarity with Thailand’s regulatory landscape allows us to anticipate common bottlenecks and respond proactively—helping your study launch on time and stay on track.
With Clinixir’s start-up services, sponsors benefit from faster site activation, greater regulatory confidence, and seamless coordination with local stakeholders. -
Effective project management is one of the most critical success factors in clinical research. Clinixir provides dedicated project managers who serve as the driving force behind each trial—ensuring that timelines are met, budgets are controlled, risks are minimized, and every deliverable aligns with regulatory and protocol expectations.

Sponsors can expect hands-on coordination from study start-up through close-out, with a clear focus on operational excellence, regulatory compliance, and transparent communication. Our project managers serve as a single point of contact, making it easier for sponsors to stay informed, make timely decisions, and maintain confidence in the trial’s progress.
Key Areas of Project Management Support
Strategic planning and execution oversight
Budget and milestone tracking
Risk assessment and mitigation planning
Oversight of site performance and enrollment progress
Protocol adherence and issue resolution
Real-time sponsor communication and reporting
Coordination with vendors, labs, and regulatory bodies
Preparation of progress updates and final study reports

Site Management and Monitoring Tools
Reliable site oversight and real-time visibility are critical to keeping clinical trials on track. Clinixir provides sponsors with the tools and infrastructure needed to actively monitor site performance, compliance, and study progress—ensuring consistency and control at every stage.
We maintain close interaction with investigational sites through a proactive site management model, supported by our clinical trial management system (CTMS). This centralized platform allows our project and monitoring teams to track milestones, flag issues early, and ensure protocol adherence across all study locations.
Sponsors Benefit From
Real-time access to site performance metrics
Centralized tracking of visit reports, deviations, and action items
Early detection of operational risks and enrollment delays
Seamless communication across sites and teams
Data-driven decision support throughout the study lifecycle
By combining strong site engagement with advanced monitoring tools, Clinixir empowers sponsors to make timely, informed decisions—improving study efficiency, reducing risk, and ensuring high-quality outcomes.
Site Management and Monitoring Tools
We maintain close interaction with investigational sites through a proactive site management model, supported by our clinical trial management system (CTMS). This centralized platform allows our project and monitoring teams to track milestones, flag issues early, and ensure protocol adherence across all study locations.
Sponsors benefit from:
- Real-time access to site performance metrics
- Centralized tracking of visit reports, deviations, and action items
- Early detection of operational risks and enrollment delays
- Seamless communication across sites and teams
- Data-driven decision support throughout the study lifecycle
Related Services
eConsent
Digital delivery and electronic agreement.
Remote Monitoring
Clinical trials advance new medical interventions.
Investigator-Initiated Trials
Sponsor and investigator in these trials.
KOL Consultation Services
KOL network offers sponsor guidance.

eConsent
Remote Monitoring
Investigator-Initiated Trials
Areas of Expertise
Clinixir brings operational excellence and regulatory insight to a broad range of therapeutic areas. With strong site partnerships, deep regional understanding, and experience supporting both global and local sponsors, we help deliver high-quality, efficient trials across Thailand. Our services span from early-phase planning to post-approval support—tailored to the specific demands of each therapeutic area.

Oncology
Oncology trials are among the most complex and resource-intensive in clinical research. Clinixir supports sponsors with full-service project management, access to leading cancer centers, and collaboration with top-tier oncologists across Thailand. Our ability to navigate evolving regulatory requirements and manage long-term, data-heavy studies ensures trials are conducted with precision and compliance.

Metabolic Diseases
Thailand faces a growing burden of metabolic disorders, making it an ideal environment for studying treatments for conditions such as diabetes, obesity, and NASH. Clinixir works closely with experienced investigators and urban hospital networks to deliver trials that reflect local disease prevalence. We bring proven strategies for protocol adaptation, lifestyle-related variable management, and data-driven decision-making.

Infectious Diseases
With its tropical climate and diverse patient population, Thailand is well-positioned for infectious disease research, including dengue, COVID-19, hepatitis, and tuberculosis. Clinixir leverages strong public-private site partnerships and a responsive regulatory framework to support fast-start trials and high-volume enrollment. Our local insight is key in managing outbreak-related studies and public health-focused research.

Herbal Medicines
As a region rich in traditional medicine, Thailand offers unique opportunities for evidence-based research on herbal and botanical therapies. Clinixir provides expertise in designing studies that meet international standards while respecting local practices. We work closely with academic institutions and regulatory bodies to ensure product safety, consistency, and scientific validity throughout the research process.

Rare Diseases
Conducting rare disease trials requires specialized recruitment strategies and high coordination across stakeholders. Clinixir helps sponsors overcome challenges in patient identification and retention by leveraging Thailand’s academic networks and referral systems. We also support early engagement with regulatory authorities to streamline study approvals and orphan drug considerations.

Medical Devices
Device trials require tailored protocols, usability evaluations, and precise regulatory alignment. Clinixir supports both diagnostic and therapeutic device studies, from feasibility through post-marketing. Our familiarity with Thailand’s Medical Device Control Division and hands-on experience managing combination product trials allows us to guide sponsors through compliant and efficient development.

Neurology
Neurological research demands careful site selection, complex endpoint monitoring, and long-term follow-up. Clinixir supports trials in Alzheimer’s, Parkinson’s, epilepsy, and neurodevelopmental disorders, with access to leading neurologists and specialist centers. We focus on ensuring data quality and patient continuity throughout lengthy trial durations, while maintaining adherence to global best practices.

Other Therapeutic Areas
Clinixir actively supports clinical trials in advanced and evolving therapeutic areas, including cell and gene therapies such as CAR-T cell therapy. These studies demand complex regulatory navigation, specialized site coordination, and high standards of operational execution—all areas where our team delivers with confidence.
We remain open and responsive to supporting sponsors working in innovative or highly specialized fields beyond traditional trial models. With strong institutional partnerships, experienced project teams, and a flexible operational framework, Clinixir is well-positioned to adapt to new study designs and cutting-edge therapies as they emerge.
As the clinical research landscape evolves, we continue to expand our capabilities to meet the future of medicine.
Oncology
Metabolic Diseases
Infectious Diseases
Herbal Medicines
Rare Diseases
Medical Devices
Neurology
Other Therapeutic Areas
Areas of Expertise
Clinixir brings operational excellence and regulatory insight to a broad range of therapeutic areas. With strong site partnerships, deep regional understanding, and experience supporting both global and local sponsors, we help deliver high-quality, efficient trials across Thailand. Our services span from early-phase planning to post-approval support—tailored to the specific demands of each therapeutic area.
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Oncology trials are among the most complex and resource-intensive in clinical research. Clinixir supports sponsors with full-service project management, access to leading cancer centers, and collaboration with top-tier oncologists across Thailand. Our ability to navigate evolving regulatory requirements and manage long-term, data-heavy studies ensures trials are conducted with precision and compliance. -
Thailand faces a growing burden of metabolic disorders, making it an ideal environment for studying treatments for conditions such as diabetes, obesity, and NASH. Clinixir works closely with experienced investigators and urban hospital networks to deliver trials that reflect local disease prevalence. We bring proven strategies for protocol adaptation, lifestyle-related variable management, and data-driven decision-making. -
With its tropical climate and diverse patient population, Thailand is well-positioned for infectious disease research, including dengue, COVID-19, hepatitis, and tuberculosis. Clinixir leverages strong public-private site partnerships and a responsive regulatory framework to support fast-start trials and high-volume enrollment. Our local insight is key in managing outbreak-related studies and public health-focused research. -
As a region rich in traditional medicine, Thailand offers unique opportunities for evidence-based research on herbal and botanical therapies. Clinixir provides expertise in designing studies that meet international standards while respecting local practices. We work closely with academic institutions and regulatory bodies to ensure product safety, consistency, and scientific validity throughout the research process. -
Conducting rare disease trials requires specialized recruitment strategies and high coordination across stakeholders. Clinixir helps sponsors overcome challenges in patient identification and retention by leveraging Thailand’s academic networks and referral systems. We also support early engagement with regulatory authorities to streamline study approvals and orphan drug considerations. -
Device trials require tailored protocols, usability evaluations, and precise regulatory alignment. Clinixir supports both diagnostic and therapeutic device studies, from feasibility through post-marketing. Our familiarity with Thailand’s Medical Device Control Division and hands-on experience managing combination product trials allows us to guide sponsors through compliant and efficient development. -
Neurological research demands careful site selection, complex endpoint monitoring, and long-term follow-up. Clinixir supports trials in Alzheimer’s, Parkinson’s, epilepsy, and neurodevelopmental disorders, with access to leading neurologists and specialist centers. We focus on ensuring data quality and patient continuity throughout lengthy trial durations, while maintaining adherence to global best practices. -
Clinixir actively supports clinical trials in advanced and evolving therapeutic areas, including cell and gene therapies such as CAR-T cell therapy. These studies demand complex regulatory navigation, specialized site coordination, and high standards of operational execution—all areas where our team delivers with confidence.We remain open and responsive to supporting sponsors working in innovative or highly specialized fields beyond traditional trial models. With strong institutional partnerships, experienced project teams, and a flexible operational framework, Clinixir is well-positioned to adapt to new study designs and cutting-edge therapies as they emerge.
As the clinical research landscape evolves, we continue to expand our capabilities to meet the future of medicine.
Latest News & Updates
Discover our latest news and updates to stay on top of clinical research trends and topics such as decentralized clinical trials, pharmacovigilance, treatment development, medical innovations, clinical trial phases, careers in clinical research, and much more.


Clinixir Announces New CEO, DR. Puchong Padungstt

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"I am very pleased to update everyone that the First Country Subject has been enrolled by Thailand Team on 11 October 2023 at site THA-764-002! After all from the start up process up to getting the approval, trainings, documentations, we have finally made it. I know this is not easy, So I want to take this opportunity to give thanks to the site, Clinixir and to the AZ Thailand study team for your hard work!"
Darwelle Manalang
Clinical Project Manager, AstraZeneca (Thailand) Ltd.
“Tech Observer would like to thank Clinixir for your close collaboration with the sponsor and us during the recent PY8 application process. Your diligent efforts in supporting the sponsor and coordinating with the sites to obtain the necessary documents for PY8 are commendable. Additionally, Clinixir's attendance for a telephone conference with the sponsor on short notice is highly appreciated. The sponsor is deeply thankful for your dedication and support. Thank you.!”
Peng Chan
Director, Tech Observer Asia Pacific Pte. Ltd.
“I am delighted to hear the news and I extend my heartfelt congratulations to each one of your team for reaching this milestone. It reflects the dedication and hard work put forth through exceptional teamwork. Let us carry forward the momentum, enthusiasm, and collaborative spirit to achieve the upcoming milestones. Great job team.”
Dr. Arun Mohan
Sr. Clinical Project Manager ,Tech Observer Asia Pacific Pte. Ltd.
“We are highly impressed with Clinixir's team, whose professionalism and expertise have greatly contributed to the success of our project.”
Suleeporn Pisitthakarn
Great Eastern Drug Co.,Ltd.
“The Sponsor extends their gratitude to K Purada and the Clinixir CRAs/CTA for their invaluable assistance and dedication in successfully cleaning and locking the ChulaVac006 database for the project's interim analysis as planned on February 16, 2024. Your efforts are greatly appreciated.”
Suttipong Chinkrua
Project Manager, Freelance
“Thank you for your kind support in ensuring the cleaning and locking of the ChulaVac006 interim analysis database as planned. The sponsor greatly appreciates your dedication.Suttipong Chinkrua.”
Suttipong Chinkrua
Project Manager, Freelance
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