Medpace is proud to announce the expansion of our microbiology capabilities at our state-of-the-art central laboratories in Cincinnati, Ohio, and Shanghai, China. With advanced technology, expert medical microbiologists, and a commitment to quality and compliance, our enhanced offerings provide Sponsors with reliable and efficient solutions tailored to the unique demands of clinical trials.
By combining traditional microbiological methods with cutting-edge molecular techniques, we deliver comprehensive insights that drive the success of your clinical trials. Our team works closely with Sponsors to design customized testing protocols that meet study requirements, enhancing the efficiency and efficacy of the drug development process. Our labs also maintain strict adherence to regulatory standards and follows Good Clinical Practice (GCP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. For standards, we follow Good Clinical Laboratory Practice (GCLP) and College of American Pathologists (CAP).
In-House Microbiology Services Include:
- Traditional Microbiology
- Quantitative culture and isolation of target pathogens from clinical specimens (cfu/mL; urine)
- Semi-quantitative culture (urine, wound, stool, respiratory, etc.)
- Gram stain
- Organism identification (MALDI-TOF MS and/or biochemical testing)
- Re-Identification of Isolates
- Identification and/or confirmatory identification of isolates
- Susceptibility testing
- Stool EIA Testing
- Clostridioides difficile GDH & Toxin A & B detection
- Enterohemorrhagic E. coli (EHEC) – Shiga toxins 1 and 2 detection
- Campylobacter-specific antigen detection
- Antimicrobial Susceptibility Testing (AST)
- AST methods:
- Broth microdilution (MIC)
- Kirby-Bauer disk diffusion
- E-test
- Agar dilution
- Breakpoint interpretation using CLSI, EUCAST, and FDA breakpoints
- Customized MIC Panels – including research compound versus comparator drugs
- AST methods:
- Mycology
- Culture and isolation of yeasts from clinical specimens
- Identification of yeasts and yeast-like microorganisms
- Antifungal susceptibility testing
- Broth microdilution (MIC) – CLSI Reference Method
- Molecular Characterization
- Syndromic testing (BIOFIRE, GeneXpert, QIAstat)
- Antimicrobial resistance gene detection
- Whole genome sequencing of isolates
Ensuring Specimen Viability and Stability
The viability and stability of microbiology specimens are critical for clinically reliable results. At Medpace, we leverage our scientific expertise to maintain optimal specimen conditions throughout their journey from patients to our central lab. Our in-house, PhD-level medical microbiologists offer expert guidance on the most effective specimen collection and transport protocols, ensuring the longest stability and specimen integrity for reliable outcomes.
Medpace Microbiology Team and Leadership
Medpace’s central labs has an experienced microbiology team overseen by a PhD-level medical microbiologist with over 12 years of experience in clinical microbiology and molecular biology. We have on-site project managers that oversee studies conducted in Cincinnati and are integrated into the global project management team.
Logan Blancett, PhD – Scientist, Clinical Laboratory, US
Dr. Blancett is a PhD scientist with over 12 years of specialized experience in multiple scientific disciplines within microbiology and molecular biology, with in-depth knowledge of bacteriology, mycology, and study of the host-pathogen interface. He is a long-standing member of the American Society for Microbiology and the Infectious Diseases Society of America.
As part of Medpace’s fully integrated CRO services, our central laboratories work in synergy with our operational and scientific teams to provide a streamlined solution for your clinical development needs. The Medpace interdepartmental, multidisciplinary approach leverages the experience of colleagues across functional and therapeutic focus areas to pool our collective knowledge to support your program. Our thorough medical, operational, and regulatory understanding of the complexities of infectious diseases trials allows us to identify potential pitfalls early and implement strategies to avoid them, helping to minimize risk and accelerate bringing new therapies to market.
About Medpace’s Central Laboratories
Strategically located in the US, Belgium, China, and Singapore, Medpace’s central laboratories have the global reach and capability to conduct studies, assist with regulatory requirements, and deliver custom solutions specific to our Sponsor’s needs. Our four wholly owned laboratories offer full-service support to six continents for phase I-IV studies, enhanced by our extensive experience running small to complex, global studies. Our standardized testing platforms, comprehensive test menu, and expert project management teams ensure seamless execution of customized projects.