Clinical Studies and Sample Biobank
Clinical studies are essential to ensure product safety and effectiveness per intended use. KSL clinical research experts provide guidance on clinical evidence collection requirements, and develops the clinical study strategy for medical device, IVD and pharmaceutical companies. KSL is well-equipped with integrated clinical laboratories in KSL Diagnostics, KSL Beutner Laboratories, KSL Pulse Scientific, and KSL Beutner Laboratories Yangzhou that are readily accessible for product clinical evaluation and clinical studies.
The clinical study services include pre-clinical and clinical study testing and support, clinical study or evaluation reports, and post market studies, as well as medical advisor review and risk consulting.
Clinical Sample Biobank
KSL has established disease-state clinical sample banks for many diagnostic markers collected and banked from regular clinical laboratory services, clinical studies and assay validation studies. The biobanks are located in the US and Canada and provide a valuable tool for clients’ clinical studies undertaken in KSL. KSL also makes these samples available for clients’ in-house studies.