Chemist wearing safety glasses and using tablet pc

Safety Testing

Providing safety assessments across a wide range of services, including chemistry, hematology, coagulation, urinalysis, serology, and drug screening.

Providing safety assessments across a wide range of services, including chemistry, hematology, coagulation, urinalysis, serology, and drug screening.

Data & Instruments

Data from Medpace central laboratories is key for assessing the 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 a strict extensive inter-laboratory comparison program.  This ensures lab data reflects the impact of a compound and not differences in testing practices. To provide continual monitoring of global consistency, the program analyzes ten split samples 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.

  • Abbott Molecular m2000 system
  • ABI-3500XL
  • Advanced Instruments Osmometer
  • Agilent Bioanalyzer
  • Aligent 4200 TapeStation
  • Applied Biosystems SimpliAmp Thermal Cycler
  • Beckman Coulter DXH Series
  • Beckman Coulter Iris IQ200
  • Beckman Coulter LH Series
  • Beckman Coulter Olympus AU Chemistry Series
  • Beckman Coulter Optima XL-70,90
  • Becton Dickinson FACSCanto 10-Color
  • Becton Dickinson FACSLyric
  • BioTek Fluorometer
  • DiaSorin Liaison
  • Epoch Microplate Spectrophotometer
  • Fluorometer, BioTek FLx800
  • Fluroskan Ascent
  • Illumina MiSeq Dx
  • Illumina NexSeq 550
  • Luminometer
  • Magnapure
  • Mesoscale Discovery Quickplex SQ
  • Mesoscale Discovery SECTOR 6000
  • Promega Glomax Luminometer
  • Protein Simple Ella
  • Qubit 3.0 and 4.0
  • Randox Daytona
  • Roche cobas 4800
  • Roche Immunoanalyzers
  • Sebia Hydrasys 2
  • Seqstudio Genome Analyzer
  • Siemens Advia 2120i
  • Siemens Atlas
  • Siemens BNII
  • Siemens Centaur XP
  • Siemens Immulite 2000 XPi
  • Stago Compact/Evolution
  • Tecan Evolyzer
  • Tecan Sunrise/Infinite m200
  • Thermo Scientific Fluoroskan
  • ThermoFisher Phadia 100/250
  • Tosoh G7, G8, G11
  • Tosoh G7, G8, G11
  • Tosoh UPLC Series
  • Waters Acquity

Chemistry & 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. Between all four global labs, we test thousands of safety samples each day.

Central Lab Services

  • 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

  • Advanced Instruments Osmometer
  • Beckman Coulter AU Clinical Chemistry Analyzers
  • Diasorin Liaison XL
  • Phadia Immunoassay Analyzers
  • Randox Daytona
  • Roche Immunoassay Analyzers
  • Siemens Advia Centaur XPT
  • Siemens Immulite 2000 XPi

Hematology & 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
  • Coagucheck
  • D dimer
  • Direct Antiglobulin Test (DAT)
  • 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
  • Fibrinogen Clauss
  • Heparin
  • Lupus Anticoagulant
  • Partial Thromboplastin Time (APTT)

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

Urinalysis & Drug Screening

Urine testing is a part of Medpace’s safety testing and biomarker services. We utilize automated urinalysis analyzers that measure a variety of parameters in urine. A microscopic review is triggered whenever there is anything unusual in the sample. New urine biomarkers are continually being added to the test menu.

Central Lab Services

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

Key Instrumentation

  • 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

Hear from Sponsors on our 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 data are more robust and reproducible than many publications I have seen in the literature, supposedly generated by specialty coagulation labs.”

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

stock photo of two female scientist working with tablet
As a full-service central laboratory, Medpace conducts safety testing for global Phase I – IV trials across multiple therapeutic areas.

Therapeutic Experience

  • AVAI / Infectious Disease
  • Cardiology / Vascular Diseases
  • CNS / Neurology
  • Dermatology
  • Device
  • Endocrinology / Metabolic
  • Gastroenterology
  • Hematology
  • Immunology
  • Musculoskeletal
  • Nephrology / Urology
  • Obstetrics / Gynecology
  • Oncology
  • Ophthalmology
  • Pulmonary /Respiratory Diseases
  • Rheumatology
  • Vaccines

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