Products designated as “Clinical Samples” are obtained from PI’s and Institutions within our Discovery Partners™ clinical research service platform. Samples are obtained under specific IRB approved clinical protocols with complete up to date informed Patient/Research subject consent with detailed patient inclusion/exclusion criteria. Case report forms (CRF’s) are designed to capture all the clinical data necessary to fulfill your Biomarker validation or clinical trials objectives. Applications: Clinical Validation studies, Clinical Trials, Biomarker Validation, Data Critical/Sensitive Companion Diagnostics, General Biomarker Research and Assay Performance studies.What are Diagnostic Remnant, or "residual" lab Samples?
Products designated as “Diagnostic Remnant” sample – otherwise known as "residual" or “leftover Lab samples are generally what remains after routine clinical testing has been performed. These samples have been coded and de-identified to protect Patient confidentiality. Under OHRP definition 45 CFR 46.102 (d)(f) these coded (de-identified) specimens are not considered subjects for Human research and do not require informed consent. Generally obtained from CLIA certified laboratories or FDA licensed blood or plasma centers. Samples are provided with only limited diagnostic testing and demographic information. Applications: Method Comparison, Assay Correlation, Precision Analysis, Equivalency Studies, General Biomarker Research and Assay Performance Studies.