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Research Development & Clinical Trials integrity, and protocol compliance, resulting in more needlower development costs for new drugs. Further, a holistic, wellfocused monitoring strategies. designed monitoring approach, leveraging near real-time flow of While adoption may be slow, there is a large amount of interest data, can offer these savings while maintaining, or even improving, and growing momentum in the industry. Helping drive those efforts is the Clinical Trials Transformation Initiative (CTTI), a public-private partnership launched in 2008. A major part of CTTI's mission is to identify monitoring practices that, through broad adoption, will increase the quality and efficiency of clinical trials. Several related collaborations are affiliated with CTTI. One example is TransCelerate BioPharma Inc., a nonprofit founded by 10 AMRI: Recipient of the 2013 Big Pharma companies in September 2012. CMO Leadership Award in QUALITY The alliance, which has since grown to 17 members, has launched five precompetitive initiatives, including a program focused on establishing a standard framework for riskbased monitoring. This includes common tools and triggers to identify risk and categorization criteria for low-, medium-, and high-risk trials. The initiative will also test a validated approach through pilot trials and be vetted by regulators. A KEY PIECE OF THE PUZZLE IS DATA In a more strategic data-monitoring approach, clinical researchers design a fit-for-purpose data verification model. Instead of reviewing trial data using the traditional 100 percent on-site SDV approach, researchers may opt for centralized data review where possible and implement a sampling plan for the on-site review of data. This sampling plan is designed prospectively based on the initial risk assessment and may be consistently applied across all sites in the study or varied based on identified risks at the region, country, and even site level. Additionally, the strategy may be designed to adjust as site risk changes throughout the progression of the trial and incorporate the escalation or deescalation of review effort based on KRIs. This approach can result in more efficient data gathering and analysis, with the potential to significantly Your values are our core. AMRI has received the 2013 CMO Leadership Award for Quality from Life Science Leader magazine. Based on research conducted by Nice Insight, survey results of more than 10,000 pharmaceutical and biotechnology H[HFXWLYHVLGHQWLÀHG$05,DVDOHDGLQJ&02LQWKHDUHD of QualityJHQHUDOO\GHÀQHGDV´WUHDWLQJDFXVWRPHU·V project as if it was its own." We thank all the companies who participated in the survey, and we will work hard to continue to provide the highest standards of quality to you. Discover, Develop, Manufacture and Deliver drugs with AMRI SMARTSOURCING™. You can rely on our global facilities and capabilities to bring your programs from discovery ELRORJ\WKURXJK$3,PDQXIDFWXULQJDQGDVHSWLFÀOODQG ÀQLVK$W$05,ZHEHOLHYHWKDWNHHSLQJ\RXUYDOXHVDW the center of everything we do enhances our shared mission to improve the quality of life. YOUR VALUES: THE AMRI SMARTSOURCING™ CORE CPHI Worldwide Booth #50D18 Global Headquarters: 26 Corporate Circle, Albany, New York, USA 12203 T: 1.518.512.2345 | E: james.grabowski@amriglobal.com | www.amriglobal.com www.amrismartsourcing.com | linkedin.com/company/amri | October 2013 @amriglobal Drug Discovery | Drug Development Manufacturing | Aseptic Fill & Finish LifeScienceLeader.com 51