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MRL International (MRLI) provides high quality and dependable global central laboratory services from its facilities in North America (located in the Cincinnati, Ohio / Northern Kentucky area) and Europe (located in Brussels, Belgium). MRLI has been in operation since 1988 and specializes in the provision of central laboratory safety and efficacy testing for new drugs under development by the pharmaceutical industry. In addition, MRLI serves as the central laboratory for large U.S. Government sponsored epidemiological and clinical studies. We are nationally and internationally known for supporting global studies involving therapeutic agents used for the lowering of lipids, control of diabetes, prevention of osteoporosis and the treatment of diseases in other metabolic areas. Since its inception in 1988, MRLI has become one of the largest and most experienced laboratories for the management of global laboratory studies involving metabolic altering agents from Phase I through Phase IV. MRL International distinguishes itself from other central laboratories in a number of ways: Knowledge: Senior management staff possesses broad experience in drug development, particularly of those drugs that influence metabolic endpoints, from IND to NDA (see Publications). Services start with assistance in protocol development to ensure that the most appropriate tests for both safety and efficacy are selected and that unnecessary laboratory testing is kept to a minimum. The majority of our senior scientific management staff has been in place over 5 years. Experience: MRLI has served and continues to serve as the central laboratory for both efficacy and safety analyses for many breakthrough, first-in-class or best-of-class drugs for the treatment of lipid, diabetes, endocrine and prostate disorders, osteoporosis and obesity developed by many of the world's top 10 pharmaceutical companies. The majority of MRLI studies have involved those major, pivotal, multi-center programs of Phase II and Phase III needed for submission of the NDA for each drug. In 1993, MRLI was selected by the National Institutes of Health (NIH) as the central laboratory for its largest and most prestigious clinical trial, the Women's Health Initiative (WHI). WHI involves 160,000 postmenopausal women followed for nearly 10 years to assess heart disease, breast and colon cancer and osteoporosis. Certifications and Proficiency Testing Participation: MRLI USA and MRLI Europe maintain accreditation from the College of American Pathologists (CAP) and the Centers for Disease Control and Prevention (CDC) - National Heart, Lung, and Blood Institute (NHLBI) Part III Lipid Standardization program. In addition, MRLI USA complies with the Clinical Laboratory Improvement Amendments (CLIA) Laboratory Certificate of Accreditation. Our laboratories participate in the proficiency programs of the CAP, CDC-NHLBI Lipid Standardization Program, Diabetes Diagnostic Laboratory (DDL) of the University of Missouri, Murex Diagnostics Clinical Chemistry Quality Assessment Program, National Institutes of Standards and Technology Round Robin Fat-Soluble Vitamin Quality Assurance Program, and NIH - WHI blinded duplicate / QC sample program. Continuity of analysis: Experience in developing and maintaining accurate, standardized, reproducible, high quality, and precise analytical results is a hallmark of MRLI for both efficacy and safety testing. Rigid attention to scientific detail, unwavering commitment over time to the use of the same equipment, methodologies and reagents, and long standing internal and external quality control and assurance practices have provided a data output that is accurate and consistent. For example, MRLI has over 13 years of continuous, quarterly certification by the NHLBI-CDC Part III Lipid standardization program. Sample collection: Efficient, accurate and rapid sample collection processes employ visit-specific kits, shipping materials, preprinted courier air bills and unique, patient-specific bar coded labels which eliminate paper requisitions (see Our Process). Data reporting: Timely, accurate and flexible-format patient reports are delivered daily by fax to investigator sites located all over the world. Results are reported in units customized to meet the needs of different geographic areas. A "real time", highly secure, internet based, remote data access system is available for Study Managers. Data management: MRLI has successfully prepared and transferred laboratory data to over fifteen different major pharmaceutical companies with a high degree of flexibility in reporting and data transfers. In each case, databases have been provided in the format specified by the sponsor. MRLI does not follow the custom of many other central laboratories in which the sponsor must accept the laboratory data output format. Therefore, MRLI is able to deliver a clean database in any format (SAS, ASCII, etc.) in a timely manner and by any mechanism (Internet, modem, disks, etc.) The data for all studies is routinely pre-processed at MRLI to ensure demographic consistency with the clinical data in the sponsor database. That is, patient specific identifiers such as initials, draw dates and visits, are verified and any queries regarding inconsistencies with the requirements of the protocol are resolved. MRLI has also extended the specifications to allow for "interim visit" data to be incorporated (for example, when additional safety data is collected).