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.

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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.

Site Management and Monitoring Tools

We recognize how important consistent interaction with investigational sites is to the success of studies. Additionally, all monitoring activities are managed through our state-of-the-art clinical trial management system (CTMS)

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.

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Sponsors Benefit From

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

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.

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

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

  • Mask group-2

    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.

  • Mask group-1

    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.

  • Mask group-7-1

    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.

  • Mask group-6

    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.

  • Mask group-4

    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.

  • Mask group

    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.

  • Mask group-7

    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.

  • Mask group-1

    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 trialspharmacovigilance, treatment development, medical innovations, clinical trial phases, careers in clinical research, and much more.

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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!"
“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.!”
“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.”
“We are highly impressed with Clinixir's team, whose professionalism and expertise have greatly contributed to the success of our project.”
“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.”
“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.”

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