---
title: Sponsor’s Local Representative and IOR Services | Clinixir
description: We offer representative and Investigator of Record (IOR) support for regulatory compliance, smooth communication with Thai authorities, and efficient importation of investigational products.
image: https://clinixir.com/hubfs/Clinix_Meta%20Image-wide.png
---

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    - [Clinical Trial Management](https://clinixir.com/services/clinical-trail)
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    - [Sponsor’s Local Representative & IOR Services](https://clinixir.com/services/sponsor-local-representative-ior)
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    - [Biometrics](https://clinixir.com/services/biometrics)
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[Email Us](mailto:enquiries@clinixir.com)

[Email Us](mailto:enquiries@clinixir.com)

[Email Us](mailto:enquiries@clinixir.com)

More results

- [Services](https://clinixir.com/services)

    - [Clinical Trial Management](https://clinixir.com/services/clinical-trail)
    - [Regulatory Affairs](https://clinixir.com/services/regulatory-affairs)
    - [Sponsor’s Local Representative & IOR Services](https://clinixir.com/services/sponsor-local-representative-ior)
    - [Pharmacovigilance](https://clinixir.com/services/pharmacovigilance)
    - [Biometrics](https://clinixir.com/services/biometrics)
    - [Site Management Organization](https://clinixir.com/services/site-management-organization)
    - [Real World Evidence](https://clinixir.com/services/real-world-evidence)
    - [Data ConneX](https://clinixir.com/services/dataconnex)
- [About Us](https://clinixir.com/about-us)

    - [Our Partners](https://clinixir.com/about-us#our-partners)
    - [Our Vision and Mission](https://clinixir.com/about-us#vision)
    - [Board of Directors](https://clinixir.com/about-us#board)
- [Updates](https://clinixir.com/blog)
- [Careers](https://clinixir.com/careers)
- [Contact Us](https://clinixir.com/contact-us)

    - [Partner Site Network](https://clinixir.com/contact-us#partner-site)

[Email Us](mailto:enquiries@clinixir.com)

# Sponsor’s Local Representative & IOR Services

International sponsors conducting clinical trials in Thailand are often required to appoint a local entity to serve as their in country representative. Clinixir offers comprehensive Local Representative and Investigator of Record (IOR) services to support full regulatory compliance, smooth communication with Thai authorities, and efficient importation of investigational products.

[Submit RFP Form](https://clinixir.com/contact-us/rfp)

**International sponsors conducting clinical trials in Thailand are often required to appoint a local entity to serve as their in-country representative. Clinixir offers comprehensive Local Representative and Investigator of Record (IOR) services to support full regulatory compliance, smooth communication with Thai authorities, and efficient importation of investigational products.**

We act as your trusted partner in Thailand, helping you navigate regulatory and operational requirements with confidence and transparency.

![Clinix\_Service-06](https://clinixir.com/hs-fs/hubfs/Clinix_Service-06.png?width=800&height=600&name=Clinix_Service-06.png)

## Local Representative Services for Clinical Trials

For sponsors without a legal entity in Thailand, a designated local representative is required to liaise with regulatory authorities, oversee ethical submissions, and ensure local compliance throughout the trial lifecycle.

### Local Representative Services

**Acting as the official in-country representative for the sponsor**

Acting as the official in-country representative for the sponsor

**Serving as the primary contact with Thai FDA and Ethics Committees**

Serving as the primary contact with Thai FDA and Ethics Committees

**Managing submission and communication of regulatory and ethics documentation**

Managing submission and communication of regulatory and ethics documentation

**Coordinating with clinical sites and investigators on behalf of the sponsor**

Coordinating with clinical sites and investigators on behalf of the sponsor

**Representing the sponsor during audits and inspections**

Representing the sponsor during audits and inspections

**Clinixir brings deep knowledge of Thai regulations, strong institutional relationships, and a proven track record supporting multinational clinical trials.**

## IOR Services for Importation of Investigational Drugs

When investigational products are imported into Thailand, Thai FDA regulations require the appointment of an Investigator of Record (IOR)—a local entity responsible for ensuring regulatory oversight of the importation process.

![Clinix\_Service-02](https://clinixir.com/hs-fs/hubfs/Clinix_Service-02.png?width=800&height=600&name=Clinix_Service-02.png)

## IOR Services

**Serving as the named IOR for investigational product importation**

Serving as the named IOR for investigational product importation

**Preparing and submitting import license applications to the Thai FDA**

Preparing and submitting import license applications to the Thai FDA

**Coordinating required regulatory documentation**

Coordinating required regulatory documentation

**Ensuring compliance with GCP and Thai import regulations**

Ensuring compliance with GCP and Thai import regulations

**Liaising with customs brokers and logistics partners, as needed**

Liaising with customs brokers and logistics partners, as needed

**Clinixir brings deep knowledge of Thai regulations, strong institutional relationships, and a proven track record supporting multinational clinical trials.**

[Submit RFP form](https://clinixir.com/contact-us/rfp)

## 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.

![asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office 1-1](https://clinixir.com/hs-fs/hubfs/asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png?width=600&height=600&name=asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png)

### 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.

![discussing-data-laptop-screen 1](https://clinixir.com/hs-fs/hubfs/discussing-data-laptop-screen%201.png?width=600&height=600&name=discussing-data-laptop-screen%201.png)

### 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.

![close-up-people-studying-language 1-1](https://clinixir.com/hs-fs/hubfs/close-up-people-studying-language%201-1.png?width=600&height=600&name=close-up-people-studying-language%201-1.png)

### 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](https://clinixir.com/hs-fs/hubfs/asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png?width=600&height=600&name=asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png)

### 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.

![discussing-data-laptop-screen 1](https://clinixir.com/hs-fs/hubfs/discussing-data-laptop-screen%201.png?width=600&height=600&name=discussing-data-laptop-screen%201.png)

### 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.

![close-up-people-studying-language 1-1](https://clinixir.com/hs-fs/hubfs/close-up-people-studying-language%201-1.png?width=600&height=600&name=close-up-people-studying-language%201-1.png)

### 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.

![asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office 1-1](https://clinixir.com/hs-fs/hubfs/asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png?width=600&height=600&name=asia-businessmen-businesswomen-meeting-brainstorming-ideas-conducting-business-presentation-project-colleagues-working-together-plan-success-strategy-enjoy-teamwork-small-modern-office%201-1.png)

### 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.

![Clinix\_About us-05](https://clinixir.com/hs-fs/hubfs/Clinix_About%20us-05.png?width=800&height=1024&name=Clinix_About%20us-05.png)

### 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

[See More Our Services](https://clinixir.com/services)

## 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

  ![Mask group-2](https://clinixir.com/hs-fs/hubfs/Mask%20group-2.png?width=875&height=353&name=Mask%20group-2.png)
  
  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

  ![Mask group-1](https://clinixir.com/hs-fs/hubfs/Mask%20group-1.png?width=875&height=353&name=Mask%20group-1.png)
  
  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

  ![Mask group-7-1](https://clinixir.com/hs-fs/hubfs/Mask%20group-7-1.png?width=875&height=353&name=Mask%20group-7-1.png)
  
  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

  ![Mask group-6](https://clinixir.com/hs-fs/hubfs/Mask%20group-6.png?width=875&height=353&name=Mask%20group-6.png)
  
  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

  ![Mask group-4](https://clinixir.com/hs-fs/hubfs/Mask%20group-4.png?width=875&height=353&name=Mask%20group-4.png)
  
  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

  ![Mask group](https://clinixir.com/hs-fs/hubfs/Mask%20group.png?width=875&height=353&name=Mask%20group.png)
  
  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

  ![Mask group-7](https://clinixir.com/hs-fs/hubfs/Mask%20group-7.png?width=875&height=353&name=Mask%20group-7.png)
  
  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

  ![Mask group-1](https://clinixir.com/hs-fs/hubfs/Mask%20group-1.png?width=875&height=353&name=Mask%20group-1.png)
  
  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.

[See More Our Services](https://clinixir.com/services)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-CMU-02.png?width=1200&length=1200&name=Clinix_Uni-CMU-02.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-CU-02.png?width=1200&length=1200&name=Clinix_Uni-CU-02.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-Khonkaen.png?width=1200&length=1200&name=Clinix_Uni-Khonkaen.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-MU-Rama.png?width=1200&length=1200&name=Clinix_Uni-MU-Rama.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-MU-Srisirat.png?width=1200&length=1200&name=Clinix_Uni-MU-Srisirat.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-MU-Tropical.png?width=1200&length=1200&name=Clinix_Uni-MU-Tropical.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-Songkla.png?width=1200&length=1200&name=Clinix_Uni-Songkla.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-TU.png?width=1200&length=1200&name=Clinix_Uni-TU.png)

![](https://242299077.fs1.hubspotusercontent-na2.net/hub/242299077/hubfs/Logo/Clinix_Uni-Ubon.png?width=1200&length=1200&name=Clinix_Uni-Ubon.png)

> "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.

![astrazeneca\_icon-logo\_brandlogos.net\_iuwml](https://clinixir.com/hs-fs/hubfs/astrazeneca_icon-logo_brandlogos.net_iuwml.png?width=54&height=65&name=astrazeneca_icon-logo_brandlogos.net_iuwml.png)

> “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.

![fggf](https://clinixir.com/hs-fs/hubfs/fggf.png?width=145&height=40&name=fggf.png)

> “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.

![fggf](https://clinixir.com/hs-fs/hubfs/fggf.png?width=150&height=41&name=fggf.png)

> “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.

![ged](https://clinixir.com/hs-fs/hubfs/Logo/ged.png?width=103&height=50&name=ged.png)

> “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

![Favi\_White](https://clinixir.com/hs-fs/hubfs/Logo/Favi_White.png?width=70&height=70&name=Favi_White.png)

> “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

![Favi\_White](https://clinixir.com/hs-fs/hubfs/Logo/Favi_White.png?width=70&height=70&name=Favi_White.png)

> "On behalf of Aestema, I would like to express our sincere appreciation for your continuous support and dedication throughout the Thai FDA registration process. Your cooperation and prompt assistance have been instrumental in achieving this important milestone. Thank you once again for your excellent support."

Jadsada Chailangka (Sunday)

Owner Representative, Head of CEO office

![209208](https://clinixir.com/hs-fs/hubfs/209208.webp?width=162&height=162&name=209208.webp)

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