1. Implementing Risk Based Monitoring (RBM) - A CRO Perspective


    from Medpace CRO / Added

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    In this presentation, Dr. Alex Artyomenko addresses the need to coordinate and collaborate across functions within both the Sponsor and CRO organizations to breed success when implementing a Risk Based Monitoring approach. Listeners will learn about taking holistic approach to building a customized adaptive monitoring program, its challenges, and perspectives for working with the medical, operational and technology teams. This topic was presented at the SCOPE Summit for Clinical Operations Executives in Orlando, FL, February 24-26, 2015.

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    • Florence Centralized Clinical Trial Monitoring


      from Ryan Jones / Added

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      Introduction of a new tool for making full digital source document verification SDV possible.

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      • Horizon ™ - HCL solution on Risk Base Monitoring


        from HCL Technologies / Added

        Find out more at www.hcltech.com Drug development process involves so many stages from pre-discovery to post-marketing, it would cost on an average 1.2 billion dollars to bring one drug to the market. In fact for any major pharma company, this cost would vary from 4 to 11 billion dollars. Out of the total cost, Monitoring alone takes 44% of the cost. HCL's solution Horizon ™ brings in significant savings to R&D cost. Our One stop solution for Centralized Monitoring and Risk based monitoring, utilizing our robust platform Analytic Engine and Independent Site Rating Panels. Our processes are driven by SOPs utilizing our In-house Tools - to name few -- Scanning Solution, iLearn, Workflow Management that provide sponsors with Savings, quality clinical trial data, and reduced study timelines.

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        • Sponsors, CROs and Risk Based Monitoring: Getting Aligned for Success


          from Medpace CRO / Added

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          Realizing the potential of Risk Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. In this webinar, Dr. David Orloff and Dr. Alex Artyomenko explore the cross-functional perspectives and process alignment between Sponsor and CRO: * Medical: influences on overall risk profile of the study, such as complexity of the design and challenges of specific indications * Regulatory: navigating international regulatory landscape while applying the RBM principles * Operational: taking a holistic approach to build a customized monitoring program * Data management: new challenges for data collection, analysis and technology requirements This webinar spotlights how drug sponsors can work with their CRO partners early in the research process to develop optimal monitoring strategies. Featured Speakers: Dr. David Orloff, Sr. Vice President Regulatory and Medical Affairs at Medpace, has over 25 years of experience in clinical research and drug development. He is an endocrinologist and a past director of the Division of Metabolism and Endocrinology Products at the FDA where he accumulated 11 years of regulatory experience as a reviewer and division director. In addition, during nearly 20 years of association with NIH, he had extensive research experience in molecular and cellular biology, adult and pediatric clinical endocrinology, and lipid metabolism. He has been with Medpace for nearly ten years and brings his clinical research experience and regulatory insights to the discussion on RBM. Dr. Alexander Artyomenko, Director, Late Phase Clinical Operations at Medpace, is a cardiologist and has over 12 years of experience in Late Phase clinical research. His unique background encompasses both medical practice and clinical research and development, with a highly successful record in planning and executing global Phase IIIb-IV studies in a variety of therapeutic areas. Dr. Artyomenko has spearheaded Medpace’s risk-based monitoring initiatives, bringing together the medical, regulatory, operational, and technology teams to deliver on the promises of RBM.

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          • CTTI-Hosted Webinar Series: TransCelerate BioPharma Presents Risk Based Monitoring Initiative


            from CTTI / Added

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            CTTI and TransCelerate have been in an ongoing dialogue about their respective efforts, including, for example, how work related to risk based monitoring (RBM) may be integrated. This webinar features a presentation by TransCelerate highlighting their RBM initiative. For more information about the CTTI-hosted webinar series, visit http://www.ctti-clinicaltrials.org/webinar-series *The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

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