Pharmacovigilance

Ensuring drug safety doesn't stop at development—it continues through every phase of a product's life. Clinixir offers end-to-end pharmacovigilance support to help sponsors protect patients, meet global safety standards, and maintain regulatory compliance at every stage.

From early clinical development through post-marketing surveillance, our team manages the continuous evaluation of drug safety data with diligence and precision. Adverse drug reactions, serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) are identified, assessed, and reported according to international pharmacovigilance requirements. Every report is reviewed by qualified professionals to ensure timely action and safeguard patient wellbeing.

Drug safety monitoring spans the pre-market, development, and post-market phases. Clinixir is equipped to support sponsors across all three, offering a consistent and rigorous approach to data collection, case processing, signal detection, and regulatory submission. Our systems and workflows are designed to comply with local and international standards, ensuring that each product is evaluated thoroughly and transparently—even after it enters the market.

Protecting patients is at the heart of what we do. Our experts work to enhance the quality of safety data and medical monitoring, ensuring all clinical research adheres to the highest ethical and scientific standards. From early trials to real-world use, our pharmacovigilance services help you maintain public trust, protect your brand, and contribute to safer healthcare systems.

Whether you're launching a new therapy or expanding an existing product’s footprint, Clinixir’s pharmacovigilance team is ready to support your safety obligations with insight, responsiveness, and care.

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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.

asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office 1-1

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.

  • "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!"

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