

Medpace Reference Laboratories (MRL), a Medpace company, has fully-owned laboratories
in North America and Europe to provide comprehensive laboratory
services dedicated to science and service.
MRL offers pharmaceutical and biotechnology
companies analytical support during all stages of the drug development
process, with over 65,000 square feet dedicated to laboratory operations
and specimen storage. Preparation, packaging, and delivery of all
supplies and materials necessary for specimen collection are also
managed within the laboratory facilities.
MRL is managed by MDs and certified
pathologists who provide consulting for clinical program design,
testing advice, laboratory method development, technology transfer,
and data interpretation during all stages of a clinical trial or
program.
Only dedicated qualified and experienced staff
are assigned to clinical projects. Our global service is reinforced
through the fully-owned network of subsidiaries of the Medpace clinical
development company.
To ensure global data integrity and high-quality,
fast turn-around times, all of our laboratories provide:
- Global analytical integrity and combinable
data through identical methodologies, reagents, calibrators, reference
ranges, consistent control programs, and strict compliance to
regulatory guidelines (GCP, GLP, ICH, IATA, and FDA); and
- Continuous monitoring of analytical quality
through participation in internal and external quality control
programs.
They are also:
- Linked to the same study-specific clinical
database (ClinTrak® Lab) for fast, consistent and
centralized study set-up, monitoring, and electronic data exchange;
- Compliant with GCP global quality assurance
system with consistent standard operating procedures, work instructions,
forms, and;
- Certified by:
- The College of American Pathologists
(CAP)
- National Glycohemoglobin Standardization
Program Level I (NGSP)
- CDC Lipid Standardization Program Part
III (LSP)
- Clinical Laboratory Improvement Amendments
(CLIA)
Services offered by MRL:
- Scientific consulting during all stages of
a clinical trial or program;
- Experienced professional and technical personnel
for efficient project set-up, management, and support;
- Full logistics services for specimen collection,
handling, and shipping;
- Comprehensive test menu including hematology,
urinalysis, chemistry, immunology, special chemistry, biomarkers,
and pharmacogenomic testing;
- State-of-the-art instrumentation and methods
for optimal accuracy and precision;
- Flexible and customizable remote data reporting
via ClinTrak Lab, including web-based data access and reporting;
- High capacity and fully computerized long-term
archival (-20°C, -70°C) and retrieval system of specimens; and
- Key Performance Indicators (KPI) and Financial
Planning Information (FPI) for optimal trial monitoring and planning.
Central laboratory services can be utilized as
a stand-alone service or in conjunction with the CRO services to allow
for bundled pricing. |