Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services

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1 Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services LABORATORY TESTING SERVICES YOUR PARTNER IN LABORATORY MEDICINE The key note of progress in the 20th century is system and organization in other words, team work. Charles H. Mayo, M.D.

2 Protocol Development Quality Service Esoteric Testing Surrogate Markers and Clinical Research Longevity and Stability Advanced Specimen Storage Patient Focused Data Management Project Management

3 Mayo Central Laboratory for Clinical Trials Drug development is a complex activity and few laboratories have both the resources and experience to offer complete services for every phase of your drug development. Mayo Central Laboratory for Clinical Trials (MCLCT) offers timely, accurate, and high-quality clinical laboratory testing services to meet the routine and esoteric testing needs of pharmaceutical and research organizations. Whether you need assistance with protocol design or result interpretation, MCLCT has the scientific expertise, the experience and the commitment of qualified customer service teams to support you in every step of your product s development. Protocol Development Nowhere else in the world is a clinical trials laboratory supported by more than 1,000 physicians and scientists for assistance in test selection and results interpretation. This wealth of expertise is a regular part of the clinical trial process and available to clients on an ongoing basis. Whether you need assistance with protocol design or result interpretation, MCLCT clients can benefit from Mayo s tradition of excellence and high standards in healthcare. 58 specialty laboratories 9,000,000 tests performed annually The latest in assays and technologies with over 40 new analytical procedures introduced each year Access to MCLCT s ability to develop clinical research-specific assays Quality Service MCLCT provides our clients with quality service throughout each clinical trial. Quality service includes more than just test results; it involves utilizing the unique medical and laboratory expertise available at Mayo. The clinical trials team follows efficient, and effective Standard Operating Procedures to provide clients with accurate, precise test results. We work closely with you to facilitate your specific clinical trial needs, helping you leverage your time and resources while we handle your specimens and data. Quality assurance programs are coordinated throughout Mayo Clinic s laboratory systems used by MCLCT. Over 30,000 internal and external proficiency tests are completed annually. Accreditation and certification is maintained through numerous quality assurance programs including: College of American Pathologists National Committee on Clinical Laboratory Standards Clinical Laboratory Improvement Act (CLIA)

4 Esoteric Testing We offer a broad menu of routine and esoteric testing, providing you everything needed in the testing arena for your entire drug development program. As one of the largest laboratories in the world, we also have access to the latest assays and technologies. When trial requirements demand the forwarding of a subject of samples to special testing facilities elsewhere in the world, MCLCT s experienced referral team can meet these special needs for you. Our automated processes allow our clients rapid-response time whether your test is routine or esoteric, saving you money and time. Surrogate Markers and Clinical Research Clinical research is a vital and progressive component of Mayo Clinic s commitment to advancing healthcare, and the assessment of biochemical changes is an integral part of that research. Mayo is dedicated to increasing the value of the measurement of biochemical changes as surrogate markers of clinical changes. This value comes from clinical outcome studies performed by medical centers that have the capability of coupling patient care, trained clinical researchers, and state-of-the-art analytical biochemistry. At Mayo, we have all three components. We firmly believe that increased utilization of modern clinical laboratories to develop, validate, and interpret surrogate markers of clinical safety and efficacy is a significant factor in accelerating drug development. Longevity and Stability MCLCT is designed to offer complex laboratory testing services to companies and investigators throughout the life of a clinical trial, no matter how long or complex the protocol. Mayo Medical Laboratories (MML) has provided dedicated laboratory services since 1971, and Mayo has supported healthcare as a private, independent organization since We are here to stay.

5 Advanced Specimen Storage MCLCT provides the latest advances in clinical trial specimen storage and electronic tracking software. Specimens are centrally managed in either our short-term or long-term facilities at -20 C or -70 C. With a specimen storage capacity of over 800,000 specimens, MCLCT s -70 storage system can accommodate a large volume of samples. Our bar-coding system allows for flexibility of user-defined sample sorting and tracking, making it easy to maintain the integrity of an audit trail for every specimen. Specimen samples can be stored to fit your storage and retrieval requirements based on current and future clinical studies. Aggregation of samples may be performed by patient, visit, test or other user-defined specifications. A specialized bar code system help facilitate accurate specimen tracking of individual samples, storage boxes, transit containers, or all of the samples for a particular study. Our controlled storage environment has 24-hour monitoring of all frozen specimens, 7 days a week. Each of our refrigeration systems has continuous backup and if needed, an additional liquid nitrogen system provides added insurance. Patient Focused The ultimate proof of clinical efficacy for any new drug or treatment is the measurement of direct benefit to the patient. Any other measurement used in the trial must be unequivocally linked to an improvement in patient outcome in order to be considered a surrogate marker of efficacy. Mayo s primary focus is on identifying and responding to the needs of the patient for: diagnosis, selection of therapy, and for monitoring response to therapy. Clinical outcome studies to validate the interpretation of surrogate markers can only be performed in an institution that not only sees patients, but has demonstrated history of expertise in clinical research.

6 Data Management MCLCT s team of programmers and data specialists is dedicated to providing accurate and timely data throughout your clinical trial. These specialists provide the high-tech infrastructure necessary to support your ongoing test results. They are focused on delivering precise, consistent data that leads to sound scientific conclusions. Our database functions support the automatic, rapid reporting of test results in a wide variety of standard reports delivered directly to the study site and designated sponsor contacts either by automated fax, mail or express courier. Electronic copies may be delivered by file transfer protocol (FTP) with encryption. Detailed data suitable for analysis or loading into your database can be made available at any time during your clinical trial study. Project Management To help guide your new drug development process towards faster regulatory approval, MCLCT devotes an entire team to your clinical research. Led by a highly trained Clinical Trial Coordinator, this team is experienced in providing personalized, responsive support and site training to ensure trial consistency. Our 24-hour toll-free help line puts you in contact with Client Service representatives, who can order supplies for you, view your latest test results online, FAX testing information, and access our protocol-specific database to advise you regarding collection and processing of laboratory specimens. Alert callbacks are provided immediately through our Client Service representatives. Visit-specific kits are designed for easy use at investigator sites. Customized kits and requisition forms may be designed for each visit in the protocol. Visit-specific assay profiles, client-defined alert values, blinding of results, management of inclusion/exclusion criteria, delta checking of values between visits, and pharmacokinetic (PK) analysis can be defined for a visit. Kits are bar-coded and clearly labeled with protocol number, visit and client name. Customized test requisition forms are included with your kit, indicating all pertinent information regarding the protocol, investigator site, specimen collection methods and transportation.

7 Mayo Central Laboratory for Clinical Trials Your partner in laboratory medicine For more information on Mayo Central Laboratory for Clinical Trials please contact: Phone: Direct: Fax: Website: Stabile Building 150 Third Street SW Rochester, Minnesota MC2989/R , Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. MAYO, Mayo Clinical Trial Services and the triple-shield Mayo logo are trademarks and/or service marks of MFMER.