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SRI International Biosciences From Idea to IND Research on Disease Mechanisms ® Drug Discovery Drug Metabolism, Pharmacokinetics, & Toxicology Services Pharmaceutical Sciences Preclinical Development Planning & Regulatory Services Clinical Analysis Laboratory Clinical Analysis Laboratory SRI’s Clinical Analysis Laboratory (formerly Quality Clinical Labs, or QCL) is fully compliant with FDA Good Laboratory Practice (GLP) regulations, and uses state-of-the-art instrumentation and data management to offer full capabilities for standard and specialized services for both human and veterinary clinical research samples. Our laboratory has a history of outstanding proficiency testing by the College of American Pathologists (CAP) and is staffed with highly qualified scientists with decades of experience in clinical laboratory testing and compliance. We have the most current GLP-validated analytical instruments, such as Advia 120, Cobas 311, Cobas 501, Stago Compact and Meso Scale Discovery Sector Imager 2400. Services are described on the following pages. Learn more Hematology Clinical Chemistry Coagulation Urinalysis Specialized Biomarkers Hematology & Clinical Chemistry SRI offers a broad range of routine and specialized hematology and clinical chemistry services. All of our analyzers are fully validated for GLP work, and we have backup instruments for hematology and clinical chemistry to ensure timely analysis of your valuable samples. SRI offers these tests and test profiles: Hematology • Eosinophil Sodium Complete Blood Count Panel • Absolute Eosinophil Total Bilirubin • White Blood Cells • Basophil Total Protein • Red Blood Cells • Absolute Basophil Triglycerides • Hemoglobin Reticulocytes Urea Nitrogen • Hematocrit Blood Smears Bicarbonate • Mean Corpuscular Volume Red Blood Cell Morphology Direct Bilirubin Amylase • Mean Corpuscular Hemaglobin Concentration • Mean Cell Hemaglobin Concentration • Red Blood Cell Distribution Width • Platelet • Mean Platelet Volume White Blood Cells Differential Panel • Neutrophil • Absolute Neutrophil • Lymphocyte • Absolute Lymphocyte • Monocyte Chemistry Lipase Individual Tests Uric Acid Alanine Aminotransferase Creatine Kinase Albumin Gamma Glutamyl Transferase Alkaline Phosphatase Aspartate Aminotransferase Urine Chemistry Calcium Individual Tests Chloride Sodium Cholesterol Chloride Creatinine Potassium Glucose Creatinine Globulin Calcium Phosphorous Potassium • Absolute Monocyte Our certified and licensed clinical lab scientists are readily available to answer any technical questions or concerns. Coagulation, Urinalysis & Biomarkers SRI offers a range of routine and specialized analyses for coagulation and urinalysis parameters. We are expanding our capabilities to include the recently FDA- and EMEA-approved biomarkers of toxicity for kidney, liver, muscle, and other target organs. SRI offers these tests: Coagulation Urinalysis • Prothrombin Time • Macroscopic urine chemistry • Activated Partial Thromboplastin Time • Fibrinogen • Others: Please Inquire examination (urine dipstick): Specific Biomarkers (under development, please inquire) • Renal (Clusterin C, Lipocalin-2, Gravity, pH, Protein, Glucose, Ketones, TIM-1, Osteopontin, Urinary Total Bilirubin, Blood, Urobilinogen, Nitrite, Protein/Albumin) Leukocytes • Microscopic: Sediment examination– White Blood Cells, Red Blood Cells, Epithelial Cells, Casts, Bacteria, Crystals, Mucus • Hepatic (Arginase-1 and PON1) • Muscle (Parvalbumin, TIMP-1, cardiac/skeletal Troponin I, cardiac Troponin T, FABP3, Myl3) • Other specialized target tissues We provide daily courier pick-up for your samples and electronic data transmission of the results to ensure an excellent turnaround time. About SRI International Biosciences SRI Biosciences carries out basic research, drug discovery and drug development, and provides contract services. SRI has all of the resources necessary to take R&D from Idea to IND®—from initial discovery to the start of human clinical trials—and specializes in cancer, immunology and inflammation, infectious disease, and neuroscience. SRI’s product pipeline has yielded marketed drugs, therapeutics currently in clinical trials, and additional programs in earlier stages. In its CRO business, SRI has helped government and other clients and partners advance well over 100 drugs into patient testing. SRI is also working to create the next generation of technologies in areas such as diagnostics, drug delivery, medical devices, and systems biology. Contact Us SRI Clinical Analysis Laboratory E-mail:[email protected] www.sri.com/biosciences /clinicalanalysis SRI Biosciences 333 Ravenswood Avenue Menlo Park, CA 94025-3493 Toll-Free: 866.451.5998 650.859.3000 Email: [email protected] Center for Advanced Drug Research SRI Shenandoah Valley 140 Research Drive Harrisonburg, VA 22802 540.438.6600 www.sri.com/biosciences About SRI International Silicon Valley-based SRI International is one of the world’s leading independent research and technology development organizations. SRI, which was founded by Stanford University as Stanford Research Institute in 1946 and became independent in 1970, has been meeting the strategic needs of clients and partners for more than 60 years. Perhaps best known for its invention of the computer mouse and interactive computing, SRI has also been responsible for major advances in drug discovery and development, networking and communications, robotics, advanced materials, atmospheric research, education research, economic development, national security, and more. The nonprofit institute performs client-sponsored research and development for government agencies, businesses, and foundations. SRI also licenses its technologies, forms strategic alliances, and creates spin-off companies. Menlo Park Headquarters SRI International 333 Ravenswood Avenue Menlo Park, CA 94025-3493 650.859.2000 Washington, D.C. SRI International 1100 Wilson Blvd., Suite 2800 Arlington, VA 22209-3915 703.524.2053 www.sri.com SRI International and Idea to IND are registered trademarks of SRI International. All other trademarks are the property of their respective owners. Copyright 2011 SRI International. All rights reserved. 02/11