Clinixir Awarded ISO 9001 Certification

Clinixir Co., Ltd. announces that it has been awarded a certificate by BSI for operating a Quality Management System which complies with the requirements of ISO 9001:2015 for the provision of Clinical Research Services. BSI was the world’s first National Standards Body, using its unique position to develop solutions to pressing issues, locally and globally. Its longstanding, independent voice helps accelerate progress towards a sustainable future. Clinixir is a leading private contract research organization in Thailand, providing full-service clinical solutions for medical innovations.

Dr. Kanokwan Pornprasit, CEO of Clinixir, said, “Our securing of this ISO certification from BSI is an important validation of the standard we have set for ourselves in providing world-class clinical research services to our clients. Thailand has a rapidly growing reputation globally as a desirable market for clinical research, where clinical trials are conducted at the highest possible international standards.”

Working with an ISO 9001-accredited CRO means our partners are guaranteed:

1. Assurance of Service – We are a trusted organization that delivers the highest standards of service.

2. Risk-based Thinking – We address risks and opportunities to deliver the best possible outcomes.

3. Quality Management System– Our quality management is assured through the buy-in of our top management.

4. Change Management – Our studies are handled methodically, with changes managed effectively.

5. Consistent Approach – All our clients receive the same standards of service.

Clinixir’s existing and recently expanded services include:

  • Conducting clinical trials for medicines, vaccines, medical devices, and nutraceuticals.
  • Product registration services for medicines, vaccines, medical devices, and nutraceuticals.
  • Report generation from electronic medical records (EMR) integration:
    • Real-World Evidence (RWE)
    • Health Economics and Outcomes Research (HEOR)
    • Prescription Audits  

Clinixir’s approach takes advantage of quality EMR data from our partnership with eight leading medical schools in Thailand. Its real-world data includes data from patients and real physicians’ practices.

According to Clinical Leader, “Clinical trials in Thailand have gained significant popularity in recent years. The country has emerged as a preferred destination for conducting trials due to its well-established infrastructure, experienced investigators, and favorable regulatory environment.” Additionally, “Thai investigators and research teams have garnered a reputation for their expertise and adherence to international standards. Many have received training and certifications from renowned institutions, ensuring the quality and reliability of clinical trial data generated in Thailand.”

About Clinixir

Clinixir is a trusted partner in developing cutting-edge treatments that improve the quality of life for people around the world. Its industry-leading services leverage advanced methods and technologies, allowing organizations to bring reliable drugs and treatment methods to the market with unparalleled efficacy. With a highly experienced team of project managers, Clinixir ensures that clinical trial projects are completed on time, within budget, and in compliance with international standards. Clinixir oversees each trial with meticulous attention to detail, from reducing data variability to meeting primary and secondary endpoints. Its commitment to adhering to strict timelines and budgets guarantees that partners achieve their research goals while delivering meaningful impact to society. 

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