SERVICES
PRECLINICAL STUDY CENTER FOR INNOVATIVE MEDICAL DEVICE
CHRONIC STUDIES & GLP

At GoldenWing Medical, we specialize in conducting comprehensive chronic research studies in compliance with the GLP system. Our state-of-the-art large animal testing facility is designed to meet the highest standards of quality and ethical research, ensuring reliable and reproducible data for our clients.


Large Animal Model Creation

Model Selection: We focus on selecting the right large animal species (such as pigs, sheep, dogs, rabbits and non-human primates) suitable for the specific medical research objectives, ensuring relevance to human physiology and disease characteristics.

Disease Induction: Our team expertly creates relevant disease models using controlled diets or surgical techniques to simulate human conditions, including metabolic diseases, cardiovascular ailments, and neurodegenerative disorders.

Validation and Monitoring: We employ a robust validation process to confirm that our animal models accurately reflect human pathophysiology. Continuous monitoring of physiological and biochemical metrics ensures the integrity and reliability of the models used in research studies.

 

Chronic Studies

Objective:

Chronic studies are designed to evaluate the long-term effects of medical devices on living organisms over an extended period. These studies are crucial for understanding the long-term effects that cannot be observed in short-term studies.

 

Methodology:

Our chronic studies are conducted in strict adherence to GLP principles, ensuring the highest level of data integrity and reliability. The methodology includes:

 

Study Design: Randomized and controlled study designs to minimize bias and ensure scientific validity.

Duration: Extended study periods, ranging from several months to years, depending on the research objectives.

Parameters: Comprehensive monitoring of physiological, biochemical, and pathological parameters.

Data Collection: Regular and systematic data collection using validated methods and equipment.

Reporting: Detailed final reports including statistical analysis and interpretation of results.

Compliance:

All chronic studies are conducted in compliance with national and international regulatory requirements, including GLP, OECD principles, and FDA guidelines.

 

Large Animal GLP Studies

Objective:

Large animal studies are essential for preclinical research, providing insights into the safety and efficacy devices, and treatments before they are tested in humans.

 

Species:

Our facility is equipped to handle a variety of large animal species, including but not limited to: Non-human Primates, dogs, pigs, sheep and goats.

 

Housing and Care: State-of-the-art housing facilities with controlled environments to ensure the well-being of the animals.

Study Design: Customized study designs to meet specific research objectives.

Monitoring: Continuous monitoring of animal health and well-being, with regular veterinary checks and assessments.

Data Collection: Systematic and validated methods for data collection, including clinical observations, laboratory tests, and imaging studies.

Ethical Considerations: Strict adherence to ethical guidelines and regulations, ensuring humane treatment and minimizing animal distress.

Compliance:

Our large animal studies are conducted in full compliance with GLP, AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) standards, and other relevant regulatory requirements.

 

Why Choose GoldenWing Medical?

Expertise: Decades of experience in chronic and large animal research.

Facilities: State-of-the-art facilities equipped with the latest technology and equipment.

Compliance: Full compliance with GLP, OECD, FDA, and AAALAC standards.

Customization: Tailored study designs to meet the specific needs of our clients.

Ethics: Commitment to ethical research practices and humane treatment of animals.


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