At Medpace Reference Laboratories (MRL), a dedicated
project management team oversees all aspects of the integrated logistics
management of a study. A project leader serves as the primary contact
for the duration of the study. Protocol review and consultation,
study set-up, collection kit design and management, specimen shipping,
blinding, eligibility reporting, and site training are all directed
by the dedicated project management team.
Certified pathologists and experienced scientists
are available for consultation on study design, testing advice,
laboratory method development, technology transfer, and data interpretation
during all stages of the study.
Our scientists have extensive therapeutic expertise
and clinical trial experience in coagulation, oncology, cardiovascular
diseases, lipids, diabetes, and other metabolic disorders.
Back to top
With over 65,000 square feet dedicated to laboratory
operations, the preparation, packaging, and delivery of all supplies
and materials necessary for sample collection and shipment are managed
within MRL. Our flexible system allows for fast preparation and distribution
of reliable study- and site-specific kits once stringent quality checks
are completed. Tracking of shipments and management of supply expiration
data are managed by MRL.
MRL also provides each study site with a customized
study binder containing detailed sample collection, handling and
shipping instructions, concise and easy-to-use quick reference charts,
and preprinted requisition forms.
Shipping is organized via our preferred relationships
with industry leading couriers based upon their documented performance
in specific geographic areas. MRL will provide suitable packaging
materials for ambient, combined, frozen, and infectious specimens.
All selected and prepared packaging and sample
collection materials and all shipping procedures are compliant with
IATA regulations.
Back to top
MRL is fully accredited by the College of American
Pathologists (CAP) and is compliant with the Clinical Laboratory Improvement
Amendments (CLIA). All Medical Technologists are certified and have
extensive experience in central laboratory operations. With expertise
in every aspect of laboratory testing — from sample collection
and test performance to blinding and result reporting — laboratory
personnel have the knowledge and understanding to accurately process
and analyze samples and report study data.
MRL features state-of-the-art instrumentation
and assay protocols providing maximum precision with minimal sample
volumes for both adult and pediatric trials. Global analytical integrity
and combinable data are provided through the use of identical methodologies,
reagents, calibrators, reference ranges, consistent control programs,
and strict compliance to regulatory guidelines (GCP, GLP, ICH, IATA,
FDA). The analytical quality is continuously monitored through participation
in internal and external quality control programs.
An array of instrumentation and methods provide
a full menu of qualifying, safety, efficacy, and endpoint tests
in the areas of chemistry, immunology, special chemistry, coagulation,
hematology, and urinalysis. Results of the laboratory testing on
most analytes are available via ClinTrak Lab within 24 hours of
sample receipt.
Back to top
MRL offers extensive specimen archiving with a
fully monitored backup system. MRL currently maintains more than 4,800
square feet of archive storage space with the capacity to store 350,000
specimens, with almost unlimited expansion potential within the same
facility.
MRL is capable of storing all types of specimens
(serum, plasma, urine, DNA, RNA, biopsies and slides, PBMC, and
PK) to temperatures as low as –180°C, in a secure and
continuously monitored archiving area. A powerful sample archive
management system, integrated in ClinTrak Lab, allows for rapid
high-volume and cost-effective specimen storage allocation and retrieval.
MRL offers the flexibility to manage specific
sample handling requirements on request of Sponsors (e.g., relabeling,
blinding), including controlled shipments to referral specialty
laboratories.
Back to top
MRL data management teams offer cost-effective,
secure, and seamless data handling based on real-time data cleanup
for prompt resolution of collection and labeling inconsistencies.
Utilizing ClinTrak Lab, a proprietary, web-based,
comprehensive management tool designed to organize the laboratory
portion of a clinical trial, MRL provides flexible electronic data
exchange customized to Sponsor requirements and other industry standards
(SAS, CDISC, HL7, etc.) and meets FDA guidelines for data submission.
When using both MRL and Medpace clinical development
services for your project, all services will have seamless integration
of set-up, performance, data management, and data transfer through
the ClinTrak system.
Back to top
ClinTrak Lab, a comprehensive proprietary software
system designed to organize the management of clinical trials, is
used to collect and analyze clinical trial data throughout the project.
Study-specific information generated by each laboratory is integrated
into ClinTrak Lab, facilitating a seamless transfer of data between
collaborating study personnel, effectively reducing project timelines.
Customized status reports and other unique reporting requirements
are made available throughout the course of a project.
ClinTrak Lab is used to provide near real-time,
customizable, study-specific, user-defined flagging and reporting
options and study monitoring tools, including graphing capabilities.
Secure, web-based reporting with study progress monitoring with
cumulative and trending reports is readily accessible to Sponsors
and investigational sites. ClinTrak Lab provides a smooth transfer
of data between key personnel, effectively reducing study timelines.
Back to top
With the increasing need for accurate monitoring
and forecasting of all aspects of study progression, MRL has defined
key performance indicators (KPI) that measure trial performance and
are shared with Sponsors at a mutually agreed upon frequency. KPI
includes the measurement of courier performance, data cleaning, data
reporting, and electronic data exchange turn-around times.
To optimize study follow-up, Sponsors are also
provided with monthly financial planning information reports to
allow for cash and resources planning, as well as the monitoring
of budget progression.
Back to top
Dedicated to providing superior laboratory services
to Sponsors, MRL performs under strict internal standard operating
procedures and external guidelines that exceed industry standards.
All MRL facilities are compliant with the Clinical
Laboratory Improvement Amendments (CLIA), and certified by the College
of American Pathologists (CAP), the National Glycohemoglobin Standardization
Program Level I (NGSP), and the CDC Lipid Standardization Program
Part III (LSP). |
