Safety Testing

Chemistry and Immunoassays

Medpace’s central laboratories offer highly automated, state of the art chemistry and immunoassay analyzers to support safety testing, serology, drug screening, and biomarker testing for all phases of pharmaceutical trials.

Central Lab Services include:

  • Bone Markers
  • Cardiovascular Biomarkers
  • Drugs of Abuse Screening
  • Endocrinology and Diabetes
  • Infectious Disease
  • Inflammation and Immunology
  • Liver Function
  • Metabolic
  • Musculoskeletal
  • Nephrology
  • Nutritional
  • Oncology
  • Routine safety chemistry

  • Key Instrumentation includes:

    • Advanced Instruments Osmometer
    • Beckman Coulter AU Clinical Chemistry Analyzers
    • Diasorin Liaison XL
    • Randox Daytona
    • Roche Immunoassay Analyzers
  • Cobas E411
  • Cobas e602
  • Modular E170
  • Siemens Advia Centaur XPT
  • Phadia Immunoassay Analyzers
  • Hematology and Coagulation

    Medpace’s central lab has a complete hematology test menu and an ever expanding specialized coagulation test menu. All four Medpace laboratory locations are NGSP Level 1 certified for Hemoglobin A1c testing, a key biomarker used in diabetes studies.

    Central Lab Services Include:

    • CBC and Differential (auto and manual)
    • HbA1c Testing
    • Sickle Cell Screening
    • Coagulation
      • Coagucheck
      • D dimer
      • Escarin Clotting Time
      • Factor IIa Antibody
      • Factor IX Antigen
      • Factor VII Activity
      • Factor VIII Activity
      • Factor VIII Antigen
      • Factor VIII Inhibitor Titers
      • Factor X Antigen
      • Factor Xa Activity
      • Factor Xa Antibody
      • Factor XIII Activity
      • Fibrinogen
  • Heparin
  • Lupus Anticoagulant
  • Partial Thromboplastin Time (APTT)
  • Plasminogen Activator Inhibitor Type 1 Activity
  • Plasminogen Activator Inhibitor Type 1 Antigen (PAI-1)
  • Plasminogen Activity
  • Prekallikrein (PKK)
  • Prothrombin Fragments 1&2
  • Prothrombin Time (PT and INR)
  • Reticulocyte testing
  • Russell’s Viper Venom
  • Thrombin Activatable Fibrinolysis Inhibitor (TAFI)
  • Thrombin Generation Assay (TGA)
  • Thromboxane B2
  • Tissue-type Plasminogen Activator Antigen (tPA)
  • Von Willebrand Factor (vWF Ag)

  • Key Instrumentation Includes:

    • Stago Coagulation Platforms
    • Tosoh UPLC systems for HbA1c analysis
  • Hematology Platforms
    • Beckman Coulter LH750 and LH780 – CBC and Auto-differentials
    • Siemens Advia 2120i -Reticulocyte hemoglobin content (CHr) and % of hypochromic RBC for iron deficiency studies
  • Over the past two years Medpace has partnered with a large pharmaceutical client in validating several new coagulation biomarkers for a new program. We are proud to share some of our partner’s comments about the success of the biomarker development:

    “It has been a great partnership, starting from our assay validations, to the first few samples analyzed for our first iDMC meeting, and now the regular high throughput of samples from 4 simultaneous trials.”

    “Your willingness to implement a fairly complex aliquot testing plan was key”

    “Your data are more robust and reproducible than many publications I have seen in the literature, supposedly generated by specialty coagulation labs.”

    Urinalysis / Drug Screening / Urine Biomarkers

    Urine testing is a part of Medpace’s safety testing and biomarker services. New urine biomarkers are continually being added to the test menu.

    Central Lab Services include:

    • Drug Screening
    • Urinalysis
      • Automated chemistry dipstick
      • Microscopic evaluation of elements
      • Urine Confirmation Testing

    Key Instrumentation includes:

    • Advanced Instruments 2020 Micro Osmometer
    • Beckman Coulter AU Clinical Chemistry Analyzers
    • Beckman Coulter Iris IQ200
    • Siemens BNII Nephelometers
    • Siemens CLINITEK Atlas

    Urine Safety Tests

    • Albumin
    • Calcium
    • Chloride
    • Creatinine
    • Glucose
  • Magnesium
  • Phosphorous
  • Potassium
  • Protein
  • Sodium

  • Urine Biomarkers

    • Angiotensinogen
    • Beta 2 Microglobulin
    • Cortisol
    • Cystatin C
    • Deoxypyridinolines
    • Epidermal Growth Factor
    • Fibroblast Growth Factor 2
    • Heparin Binding Epidermal Growth Factor
  • Kidney Injury Molecule – 1
  • Monocyte Chemotactic Protein – 1
  • N-Acetyl-beta-D Glucosaminidase
  • Neutrophil gelatinase-associated lipcalin
  • Osmolality
  • Retinol Binding Protein
  • Transforming Growth Factor
  • Learn More about Medpace Central Laboratory Capabilities