To browse Medpace Reference Laboratories' capabilities, select an item from the list below.
Dedicated project management
Customized logistics services
Data management and electronic data exchange
ClinTrak® Remote data access
Medpace Reference Laboratories (MRL) delivers maximum precision with minimal sample volumes for both adult and pediatric trials. Featuring fully-owned state-of-the-art instrumentation and assay protocols, every MRL 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.
Every Medpace Medical Technologist is certified by the American Society for Clinical Pathology (ASCP) in the US or equivalent for lab locations outside the US. All of our laboratory personnel possess the knowledge and understanding to process and analyze samples and report study data accurately and efficiently. With extensive experience in every aspect of central laboratory operations, including sample collection, test performance, blinding, and result reporting, we are experts in efficacy and endpoint tests focused on lipids, cardiovascular, diabetes, and oncology biomarkers. We also provide a full menu of instrumentation and methods for safety tests in the areas of chemistry, immunology, special chemistry, coagulation, hematology, urinalysis, serology, and drugs of abuse, with reporting within 24 hours for most analytes.
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 labs.
MRL is unique in offering:
- Extensive method validations according to NCCLS 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 non-routine analytes, ensuring superior long term stability and consistency.
- Relevant and stringent Internal Quality Control (IQC) programs.
- Extensive External Quality Control programs (CAP, CDC, NGSP).
- Interlaboratory Comparison Program with weekly submission of samples.
- Extensive system of in-process delta checks and recheck criteria for nearly every lab parameter.
Capable of storing all types of specimens, including serum, plasma, urine, DNA, RNA, biopsies and slides, PBMC, and PK, at a variety of temperatures down to –180°C, MRL offers extensive specimen archiving within a completely secure and continuously monitored environment with multiple, redundant UPS/CO2 backup. With over 4,800 square feet of archive storage space onsite and the capacity to store 1,000,000+ specimens, MRL specimen archiving is expandable to an almost unlimited capacity within the same facility. Sample archive management is fully-integrated into our Laboratory Information Management System (LIMS), ClinTrak Lab®, allowing for rapid high-volume and cost-effective specimen storage allocation and retrieval.
Medpace Reference Laboratories offers the flexibility to manage specific sample handling requirements (e.g. relabeling, anonymization, etc.), including controlled shipments to referral speciality laboratories, on request.
Dedicated Project Management
At Medpace, a dedicated project management team oversees every aspect of the integrated logistics administration of your study, with a project leader serving as a single point-of-contact for Sponsors. Protocol review and consultation, study set-up, collection kit design and management, specimen shipping, blinding, eligibility reporting, and site training are all directed by your dedicated team. All sites are monitored to ensure that they have current supplies and instructions to meet the laboratory sampling requirements and that the samples being submitted are processed correctly to ensure optimal specimen quality.
With extensive clinical trial experience in a variety of areas such as coagulation, oncology, cardiovascular diseases, lipids, diabetes, and other metabolic disorders, our certified pathologists and scientific experts consult on study design, testing advice, laboratory method development, technology transfer, and data interpretation during every phase of drug development.
Utilizing our unique partnering philosophy, MRL project managers work closely with your team to ensure that updates, such as protocol amendments and changes in site personnel, are addressed appropriately and in a timely manner. Laboratory Directors and senior management are involved at every step to ensure all issues are discussed in real time and immediately resolved.
Customized Logistics Services
With over 65,000 square feet dedicated to laboratory operations, MRL has complete control of the preparation, packaging, and delivery of all supplies and materials necessary for sample collection and shipment. Our flexible system ensures rapid preparation and distribution of reliable study and site-specific kits following stringent quality checks.
Our intelligent supply chain management system is tailored to anticipate and responds to your specific needs and provides full lot and expiry date tracking for production and on-time distribution of customized sample collection kits. MRL provides suitable packaging materials for ambient, refrigerated, frozen, and infectious specimens, and shipping managed through preferred relationships with the best couriers in industry based upon their documented performance in specific geographic areas. You will receive a customized Study Folder with detailed sample collection, handling and shipping instructions, concise and easy-to-use quick reference charts, and preprinted requisition forms.
All materials, including selected and prepared packaging and sample collection products, and all shipping procedures are compliant with International Air Transport Association (IATA) regulations.
Data Management & Electronic Data Exchange
The MRL Data Management team delivers secure, seamless, and cost-effective data handling based on real-time data clean-up for prompt resolution of collection and labeling inconsistencies. Utilizing the Medpace LIMS, ClinTrak Lab®, MRL provides flexible electronic data exchange customized to meet your needs and compliant with industry standards (SAS, CDISC, HL7 and others) and FDA guidelines for data submission. All services, including set up, performance, data management, and data transfer, are seamlessly integrated into your customized ClinTrak reports.
ClinTrak Remote Data Access
ClinTrak Lab® provides a smooth transfer of data between key personnel – including Medpace, Sponsors, and investigative sites – effectively reducing study timelines and maximizing results. ClinTrak Lab® provides customizable, study-specific, user-defined flagging and reporting options and study monitoring tools, including graphing capabilities and secure, web-based reporting provides near real-time access to study progress monitoring and cumulative and trending reports.
MRL is dedicated to providing superior laboratory services to our partners and performs under strict internal standard operating procedures and external guidelines that exceed industry standards.
As proof of our dedication to providing the highest quality of central laboratory services, all Medpace Reference Laboratories facilities are compliant with the Clinical Laboratory Improvement Amendments (CLIA)*, and are 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).