Investigator-Initiated Trials (IITs)
Investigator-Initiated Trials (IITs) are clinical trials in which the investigator assumes the roles of both the sponsor and the investigator.
Empowering Independent Research with Professional CRO Support
Investigator-Initiated Trials (IITs) are clinical studies where the investigator assumes both the sponsor and investigator roles. In these trials, the investigator is responsible for developing the protocol, initiating the study, and administering the investigational product—while also overseeing the trial’s conduct and data collection.
Although the investigator leads the study, the distinct responsibilities of sponsor and investigator still apply, requiring both scientific expertise and operational oversight.
Clinixir supports the success of IITs through expert clinical data management, statistical analysis, and regulatory guidance—ensuring research is not only scientifically sound, but also compliant and publication-ready.

What We Offer
Protocol review and feedback to identify potential clinical or operational challenges
Site and investigator recommendations based on real-world insights
Therapeutic area alignment with standard of care and treatment pathways
Feasibility guidance on patient population and recruitment strategies
Expert input during study planning and proposal development
Key Considerations for a Successful IIT Application
The process of initiating an IIT typically begins with a concept note submitted to a sponsor, followed by a full proposal. These proposals are carefully reviewed and evaluated against several key criteria:
The Applicant’s Background & Expertise
Assessment of the investigator’s qualifications and experience to ensure their ability to carry out the study effectively and independently.
Addressing Gaps in Literature & Unmet Medical Needs
The proposed research should demonstrate its relevance—whether by filling clinical knowledge gaps, exploring off-label uses, or addressing important unmet needs.
The Overall Quality of the Study
Evaluators look at the scientific rigor of the proposal, including study design, rationale, methodology, chosen endpoints, and statistical analysis plan.
The Study’s Financial Feasibility
Sponsors consider whether adequate funding is available and whether the study has a realistic, well-planned budget and necessary resources.
Adherence to Ethical Standards
All IITs must comply with Good Clinical Practice (GCP), applicable local laws, institutional guidelines, and relevant regulatory requirements.

Why IITs Matter
IITs play a vital role in advancing medical knowledge through independent research. These studies generate non-industry-sponsored data, which can enhance the credibility of findings and provide new insights that support product development or market expansion.
By improving clinical outcomes and contributing to scientific literature, IITs help drive innovation across the healthcare ecosystem.
How Clinixir Supports IITs
We understand the unique needs of investigator-led studies and provide tailored support to help bring your research to life. Our services include:
Clinical data management and statistical analysis
Study database setup and validation
Safety reporting and compliance coordination
Medical writing and publication support
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.
-
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.
"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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