临床前和临床服务

Pre-Clinical and Clincial Service

Kanglife, Spanish office and Thailand office have reached strategic cooperation with many laboratories and hospitals in Europe, Thailand and other regions, and can provide customers with a wealth of laboratory and clinical resources at home and abroad to meet the requirement of analytical performance verification, and preclinical performance validation, clinical trail and post-market performance evaluation, etc.

Service Items

Analytical Performance Verification

Analytical performance evaluation is one of the important supporting material for evaluating product safety and effectiveness. Scientifically and rationally carrying out product analytical performance evaluation and determining the various analytical performance indicators of the product is a key process in product design and development.

Preclinical Performance Validation

Before formal clinical trials, use small-scale clinical samples to verify and conduct thorough experiments on the clinical performance of the product.

Clinical Trail

Clinical trail refers to systematic studies on the clinical performance of in vitro diagnostic medical devices in corresponding clinical environments. The purpose of clinical trail is to prove that the in vitro diagnostic medical device can meet the requirements for its intended use and to determine the applicable population and indications of the device. The result of clinical trails provides effective scientific evidence for the confirmation of safety and effectiveness of in vitro diagnostic medical devices and risk-benefit analysis.

Post-Market Performance Study

The purpose of post-market performance studies is to expand understanding of the effectiveness of marketed IVD medical devices and to confirm the safety of the IVD medical device for a broad range of people under actual use conditions. From the perspective of clinical value, post-market performance studies are an important supplement and improvement to registered clinical research data. They are the collection of data on the application of in vitro diagnostic medical devices in the actual clinical real world. Compared with registered clinical studies designed under ideal conditions The data have greater guiding significance for clinical application.

Service Content

Laboratory and Clinical Resources

Kanglife, Spanish office and Thailand office have reached strategic cooperation with many laboratories and hospitals in Europe, Thailand and other regions, and can provide customers with a wealth of laboratory and clinical resources at home and abroad to meet the requirement of product testing, analytical performance verification, and preclinical performance validation, clinical trials and post-market performance evaluation, etc.