Mayo Alliance for Clinical Trials

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1 Mayo Alliance for Clinical Trials A Division within Mayo Clinical Trial Services PROFESSIONAL CLINICAL TRIALS SERVICES ADVANCING PATIENT CARE THROUGH SCIENTIFIC DISCOVERY It is a great thing to make scientific discoveries of rare value, but it is even greater to be willing to share these discoveries and to encourage other workers in the same field of scientific research. William J. Mayo, M.D.

2 Mayo Alliance for Clinical Trials Mayo Alliance for Clinical Trials (Mayo ACT) was formed to offer the best of both worlds that is, the operational efficiencies of contract research organizations and the clinical and scientific excellence of an academic research organization to provide professional clinical trial management services committed to: Academic Center Mayo Trials n Quality Timeliness Personal Attention Stability Quality Scientific and data integrity are ensured through the integration of clinical excellence with a proven operational infrastructure. We ve responded to your needs by merging the operational efficiencies of CROs with the clinical excellence of AROs to provide science and service excellence. Timeliness Faster regulatory approval is supported through our validated, reliable processes and measures. Personal Attention Dedicated Mayo project management teams proactively collaborate with your management teams to monitor study progress and respond to issues quickly and decisively. Stability Our long term focus to clinical excellence provides you with a stable team of professionals during the entire duration of your study. Mayo Alliance for Clinical Trials is a fully self-contained group bringing dedicated contract, regulatory, quality and data management expertise through a service provision committed to excellence and timeliness.

3 SERVICES FEATURES Protocol Consultation is available and includes scientific review and clinical/biostatistical input for sponsor protocols. Mayo ACT works closely with many Mayo Clinic research professionals involved in over 5,000 active protocols. Site Recruitment and Qualification efforts are ongoing and selective. Recruitment sources are national in scope and target investigators from among the most active specialties. Trial Management services are centralized for efficiency and responsiveness. Our teams feature a single point of contact who manages processes to help integrate your needs with our team members. Regulatory Management is committed to proactively identify and resolve any regulatory issues that stand in the way of a quality and timely study outcome. Legal/Contract Management is dedicated to industry-sponsored research and provides rapid, responsive service for expedited contract execution. Data Management begins with a validated system, monitored by quality and productivity rules, and designed to ensure data consistency. Biostatistics expertise is provided by experienced professionals focused on the accurate collection, organization and analysis of clinical data for faster regulatory review and study completion. Quality Assurance measures such as document management, personnel competency and training and our Quality System Essentials (QSE) program ensure the reliability you expect. Mayo Alliance for Clinical Trials is dedicated to quality study results that can only come about through personalized service conducted in a timely, cost effective manner. Our mission is to help you advance the science of medicine through the merging of scientific and service excellence.

4 SERVICES OVERVIEW Mayo Alliance for Clinical Trials provides a full range of integrated services designed to complete your study on time and on budget. These services include: Protocol Consultation Site Recruitment and Qualification Trial Management Regulatory Management Legal/Contract Management Data Management Biostatistics Quality Assurance Additional Services Supporting Clinical Trials Mayo Clinical Trial Services can provide important service line support in addition to Mayo ACT. Mayo Central Laboratory for Clinical Trials can provide medical and scientific attention to rapid assay development for the diagnostic test component of your studies. Our 58 specialized laboratories are among the most recognized in the world in terms of quality and reliability. M I Elevation Mayo Angio and ECG Core Laboratories are designed for the rigors of clinical trials and are under the direction of Mayo Clinic staff cardiologists providing computer-assisted analysis in a validated setting.

5 Mayo Alliance for Clinical Trials Advancing patient care through scientific discovery. For more information on Mayo Alliance for Clinical Trials please contact: Phone: Fax: Stabile Building 150 Third Street SW Rochester, Minnesota , 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. MC2285/R0602

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