Highlighted Therapeutic Expertise

Autoimmune and Inflammatory

Medpace’s central laboratories have an extensive selection of tests relevant to autoimmune and inflammatory diseases. There over 50 inflammatory biomarkers on a validated test menu.  Assays are validated on specialized instrumentation as well as a large menu (>100) of validated ELISA assays and multiplexed assays.

Central Lab Services

Key Instrumentation

Anti-Double Stranded DNA (DsDNA) antibodies C-Reactive Protein (high and ultra-sensitivity) Advia Centaur XPT Sebia Hydrasys
Antinuclear Antibodies (ANA) Complement Testing (C3, C4, C4a, C5a, Bb) MSD Secto 6000 Siemens BNII Nephelometers
Anti-Cardiolipins antibodies (IgA, IgG, IgM) Immunoglobulins Randox Daytona Stago Compact
APS (antiphospholipid syndrome) markers Various cytokines, chemokines, and growth factors (see Medpace test menu) Roche Immunoassay Analyzers Tecan Evolyzer
Phadia Immunoassay Analyzers Tecan INFINITE
Tecan Sunrise

Lipid Disorders, Cardiovascular, and Metabolic Diseases

Medpace’s central laboratories have unparalleled experience and expertise in the development of lipid and cardiovascular modifying therapies. Key staff involves doctors, managers, and technologists with considerable expertise in the area of central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long term global lipid and cardiovascular trials.

  • Since 1985, this core group has been part of central laboratory operations for virtually every successful New Drug Application (NDA) involving lipid modifying therapies including, but not limited to, all “statins”, apo B antisense, and omega-3 agents.
  • Recently Medpace has provided efficacy analysis for two Proprotein convertase subtilisin/kexin type 9 (PCSK9) mAb inhibitors that supported acceptance of the FDA biologics license application (BLA), European & Global filing, and subsequent approvals by the FDA and EMEA.
  • Medpace has been the global central laboratory for Phase I – IV trials involving numerous lipid altering mechanisms including Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition involving monoclonal antibodies, RNA interference, and fusion proteins, cholesterylester transfer protein (CETP)  inhibition, Diacylglycerol Transferase (DGAT-1) inhibition, peroxisome proliferator-activated receptor (PPAR)  agonism, omega-3 fatty acids, niacin analogs, and modifications of other biomarkers known to affect lipid metabolism such as Apo CIII and ANGPTL3 (angiopoietin-like 3).

Central Lab Services

Key Instrumentation

Apolipoprotein Analysis:  AI, AII, AV, B (Total), B-48, B100, CII, CIII, E Lipid Profile (Total Cholesterol, Triglyceride, HDL-C, LDL-C) Prebeta-1 HDL Beckman Coulter AU Clinical Chemistry Analyzers
Cholesteryl Ester Transfer Protein (CETP) Activity, Mass Lipoprotein (a) Preparative Ultracentrifugation (PUC) for lipoprotein fractionation Beckman Optima Ultracentrifuges
Free Fatty Acids Lipoprotein-associated Phospholipase A2 (LpPLA2) Activity and Mass Remnant Lipoprotein Cholesterol (RLP-C) Siemens BNII Nephelometers
Free Glycerol Oxidized LDL Retinyl Palmitate Randox Daytona
HDL Cholesterol – Precipitation with dextran sulfate (reference method), “direct” or homogenous enzymatic method, Preparative Ultracentrifugation (PUC) PCSK9, total and free Waters AcQuity UPLC H Class System
LDL Cholesterol – (Friedewald, DeLong, Hopkins), “direct” or homogenous enzymatic method, PUC Phospholipids

All four central lab locations globally participate in and are certified in the CDC (Center for Disease Control and Prevention) Lipid Standardization Part III Program for total cholesterol, triglyceride, High-Density Lipoprotein Cholesterol (HDL-C), and Low-Density Lipoprotein Cholesterol (LDL-C). Many lipid trials require LDL-C by the gold standard reference method, preparative ultracentrifugation (PUC), which is performed in high volume at Medpace with over 2,000 analyses monthly. Determination of efficacy, and safety, necessitates an accurate evaluation of drug effect, without the confounder of inaccurate data due to a less than optimal laboratory methodology. Medpace labs will get involved early in a drug development program, to aid in the determination of the best method for a clinical trial.

Oncology

Along with our experienced CRO and strategic anatomical pathology lab partners, Medpace’s central lab has broad experience in managing oncology clinical trials.   Medpace’s central lab has a team of PhD directors overseeing the expansion of Medpace’s oncology test menu with newly validated biomarkers in support of our clients’ oncology programs.

Central Lab Services

Alpha Fetoprotein Fibroblast Growth Factors (2, 21, 23) Vascular Endothelial Growth Factor (VEGF) FISH
CA125 MIA (CD-RAP) VEGF-A IHC Stains – over 150 validated IHC stains
Carcinoembryonic Antigen Neuron Specific Enolase VEGF-R2 Tissue Arrays
CK-18 M30 Apoptosense Prostate-Specific Antigen Full specimen processing capabilities, including Special Stains
CK-18 M65 EpiDeath S-100 Paraffin block embedding (FFPE) Aperio whole slide imaging – web-accessible and interactive
Fecal Occult Blood Vascular Adhesion Molecule (VCAM-1) Sectioning

Medpace’s strategic partnership provides our clients with access to board-certified pathologists and state of the art histology services.

Infectious Diseases

Infectious disease studies have grown in complexity with traditional microbiology methods increasingly supplemented with new molecular techniques, providing rapid and accurate data, facilitating improved understanding of disease mechanism and enhance clinical outcomes.  Medpace’s central laboratories’ in house capabilities coupled with strategic laboratory partnerships with top labs in microbiology and virology provide the specific testing required for each study.  This approach streamlines timelines, simplifies requirements for sites, and provides a centralized model for communication.

Medpace Advantages for Infectious Diseases Studies

  • Access to top research scientists who are therapeutically focused on infectious disease, deliver regulatory-quality reports and meet the tight timelines demanded in ID trials
  • With Medpace central labs coordinating the shipping between sites and labs around the world, logistics are greatly simplified, resulting in higher efficiency
  • Specialty labs integrate seamlessly with Medpace’s full-service approach to clinical trial management

Central Lab Services

Bacterial Identifications Genotyping In vitro drug susceptibility testing Molecular Characterization
Fungal Identifications Infectious Disease Serology Microbial Cultures TB Testing (Quantiferon Gold)
Viral Loads