Central Lab Analytic Control and Accreditations
Providing superior laboratory services to our partners while performing under strict internal standard operating procedures and external guidelines that exceed industry standards.
Providing superior laboratory services to our partners while performing under strict internal standard operating procedures and external guidelines that exceed industry standards.
Scientific Laboratory Expertise
The laboratory is led by a team of PhD scientists who are experts in laboratory methodologies and assay development. Our PhDs engage with clients early in the study set up process. They consult on the study design, laboratory methods, biomarker selection, and technology transfers.
Every Medpace Medical Technologist is certified by the American Society for Clinical Pathology (ASCP or CLS) in the US (or equivalent for the staff at Medpace Laboratories locations outside the US). All of our laboratory personnel have extensive experience in every aspect of central laboratory operations from processing samples, performing analysis, and reporting study data accurately and efficiently.
Our capabilities include an extensive list of instrumentation and methodology including flow cytometry, molecular sequencing, histology, HPLC, coagulation, and immunoassays, in addition to safety testing for chemistry, hematology, urinalysis, serology, and drugs of abuse testing.
The Only U.S.-Based CRMLN Laboratory
Medpace is proud to be the only US-based laboratory certified by the CDC to be member of the Cholesterol Reference Method Laboratory Network (CRMLN), a global network of highly-specialized reference laboratories recognized for excellence in lipid testing. CRMLN certification is awarded to laboratories that demonstrate exceptional accuracy, precision, and long-term analytical performance using CDC-traceable reference methods for cholesterol and lipid measurements.
Under the scientific direction of Dr. Santica Marcovina, Medpace’s CRMLN-certified laboratory has supported assay standardization for diagnostic manufacturers and applies the same rigorous reference methods to monitor the quality of lipid analyses performed in clinical trials. For Sponsors developing therapies targeting dyslipidemia, cardiovascular disease, and related metabolic disorders, this distinction provides added confidence in the reliability, consistency, and scientific integrity of critical lipid endpoint data.
Medpace Central Laboratories Accreditations
Featuring fully owned state-of-the-art instrumentation and assay protocols, every Medpace central laboratory location is fully accredited by the College of American Pathologists (CAP), all are independently certified, participate and meet CDC Part III lipid standardization, all are Level 1 NGSP for HbA1c and the USA lab is CLIA Certified.
United States
- College of American Pathologists (CAP) Accreditation
- CLSI Membership
- NGSP Level I
- Centers for Disease Control and Prevention- Lipid Standardization Program (CDC-LSP)
- Clinical Laboratory Improvement Amendment (CLIA)
- Cholesterol Reference Method Laboratory Network (CRMLN)
- Integrated BioBank of Luxembourg (IBBL) Biospecimen Proficiency Program
- New York State Department of Health Certificate of Qualification
- Pennsylvania Department of Health Clinical Laboratory Permit
- North American Specialized Coagulation Laboratory Association (NASCOLA) administered through ECAT
- New York State Department of Health Laboratory Permit
- California Clinical and Public Health Laboratory License
- ISO 15189 Accreditation
Singapore
- College of American Pathologists (CAP) Accreditation
- CLSI Membership
- NGSP Level I
- Centers for Disease Control and Prevention – Lipid Standardization Program (CDC-LSP)
- Integrated BioBank of Luxembourg (IBBL) Biospecimen Proficiency Program
- Ministry of Health (MOH) License
- HSA External Quality Assessment Program
Biorepository Services
Analytic Control
Analytical quality is continuously monitored via extensive participation in internal and external quality control (QC) programs. Global analytical integrity and combinable data are maintained utilizing identical methodologies, reagents, calibrators, reference ranges, consistent control programs, and strict compliance to regulatory guidelines in all Medpace Laboratories.
Medpace Central Laboratories Analytic Advantages:
- Wholly owned, custom built laboratories allow for standard, harmonized instrumentation and methods at all Medpace Laboratories
- Extensive method validations (with industry leading timelines) set up according to CLSI guidelines
- Careful selection of calibration standards to ensure long-term consistency
- CDC-certified in-house customized and prepared serum pools for calibration and quality control of lipid testing
- In-house prepared QC pools for many analytes, ensuring long term stability, consistency, and ability to monitor performance of assays across multiple lots of manufactured QC
- Extensive External Quality Control programs (CAP, CDC, NGSP, NIST, and IBBL)
- Inter-laboratory Comparison Program with weekly analysis of samples and monitoring of results
- Extensive system of in-process delta checks and recheck criteria for nearly every lab parameter