Safety Testing

Data and Instruments

Data from Medpace central laboratories has been key for assessing safety, tolerability, and efficacy of new drugs in development. With the increasing complexity and global scale of many clinical trials, it is important to maintain testing harmonization among each Medpace laboratory. In order to ensure that all results generated globally are harmonized, Medpace labs has an extensive inter-laboratory comparison program.  This ensures lab data reflects the impact of a compound and not differences in testing practices.  The program is performed weekly at each Medpace laboratory to provide continual monitoring of global consistency. Ten split samples are analyzed weekly on the same day in all Medpace labs globally for analytes across all major platforms. Additional assays can be added to monitor testing specific to a clinical program. Medpace utilizes global standard operating procedures, and identical assay platforms, calibrators, and quality control material.

Key Instrumentation

Abbott Molecular m2000 system Epoch Microplate Spectrophotometer Siemens Atlas
Advanced Instruments Osmometer Fluorometer, BioTek FLx800 Siemens BNII
Agilent Bioanalyzer Illumina MiSeq Dx Siemens Centaur XP
Beckman Coulter Iris IQ200 Luminometer Stago Compact/Evolution
Beckman Coulter LH Series Mesoscale Discovery SECTOR 6000 Tecan Evolyzer
Beckman Coulter Olympus AU Chemistry Series Promega Glomax Luminometer Tecan Sunrise/Infinite m200
Beckman Coulter Optima XL-70,90 Randox Daytona Thermo Scientific Fluoroskan
Becton Dickinson FACSCanto 10-Color Roche Immunoanalyzers ThermoFisher Phadia 100/250
BioTek Fluorometer Sebia Hydrasys 2 Tosoh G7
DiaSorin Liaison Siemens Advia 2120i Tosoh UPLC Series
Waters Acquity

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

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

Key Instrumentation

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

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

Key Instrumentation

Stago Coagulation Platforms
Tosoh UPLC systems for HbA1c analysis
Hematology Platforms, including:
Beckman Coulter LH750 and LH780 – CBC and Auto-differentials
Siemens Advia 2120i -Reticulocyte hemoglobin content (CHr) and % of hypochromic RBC for iron deficiency studies

Comments from Sponsors on Coagulation Services

Medpace partnered with a large pharmaceutical client and validated several new coagulation biomarkers for their new program. We are proud to share some of our partner’s comments about the success of our biomarker development and collaboration.

“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 four 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

Key Instrumentation

Drug Screening Advanced Instruments 2020 Micro Osmometer
Urinalysis, including: Beckman Coulter AU Clinical Chemistry Analyzers
 Automated chemistry dipstick Beckman Coulter Iris IQ200
 Microscopic evaluation of elements Siemens BNII Nephelometers
 Urine Confirmation Testing Siemens CLINITEK Atlas

Urine Safety Tests

Albumin Magnesium
Calcium Phosphorous
Chloride Potassium
Creatinine Protein
Glucose Sodium

Urine Biomarkers

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