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Follow on Google News | Announcing CHI’s Clinical Project Management Forum, June 2-3, 2015, Boston, MAManaging Risk and Improving Performance in Outsourced Clinical Trials
Agenda at-a-Glance: Tuesday, June 2 Clinical Trial Vendor Oversight: The CRO Strategic Partner Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC) Using Risk-Based Management to Improve the Quality of Your Clinical Trials Michael Howley PA-C, Ph.D., Physician Assistant – Certified Faculty Coordinator, MBA Healthcare Concentration, Associate Clinical Professor, Department of Marketing, LeBow College of Business, Drexel University Case Study: Using Analytics and Visualization Tools to Identify and Evaluate Risk and Support Decision-Making Rosanne Petros, PMP, Associate Director, Clinical Research, Clinical Research Manager US Global Clinical Trial Operations, The Americas, Merck Research Laboratories Implementing Risk-Based Monitoring – It Is Not Rocket Science! Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd. Case Study: Can Big Data Help in Detecting and – Even More Importantly – Preventing Fraud in Clinical Trials? Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis Dinner Short Course: Quality by Design in Clinical Research: Is This Only for the Protocol? Wednesday, June 3 Cyber-Connectedness with Your CRO: Compliance and Peace of Mind Mollie Shields-Uehling, President and CEO, SAFE-BioPharma Association Betsy Fallen, Global Head of Program and Business Development, SAFE-BioPharma Association Case Study: Applying Strategies to Successfully Operationalize Atypical Studies of Rare Diseases Through a Successful Global Partnership Patricia Nowowieski, Head, Global Clinical Operations, Cambridge, Global Clinical Operations, Alexion Pharmaceuticals Donna Holloway, Director, Clinical Project Management, Quintiles Case Study: Adaptive Monitoring: How to Manage Sites Without Visiting Them Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis Building a Global System: Promoting Accountable Research Greg Koski, Ph.D., M.D., Co-Founder & President, ACRES; former Director, Office for Human Research Protections, U.S. Department of Health and Human Services Risk-Based Approached to Outsourced Relationships: Lynnette Wright, Global Contracts & Outsourcing Lead (GCOL), Astellas Pharma Global Development, Inc. Case Study: Predictive Modeling to Optimize Enrollment Outcomes in Outsourced Phase III Studies: A Case Study Moe Alsumidaie, MBA, MSF, Chief Data Scientist, Annex Clinical Integrated Quality Oversight Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium Writers and editors are invited to attend. To request a press pass, email Lisa Scimemi, lscimemi@healthtech.com. For details on sponsorship, exhibit and lead generation packages, contact Ilana Quigley, Tel: 781-972-5457, iquigley@healthtech.com. For more information, visit http://www.ClinicalTrialSummit.com/ About Clinical Trial Oversight Summit Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This three-day summit will brings together 250+ highly targeted decision makers and include presentations, case studies, interactive breakout discussion groups, dinner short courses, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness. http://www.ClinicalTrialSummit.com About Cambridge Healthtech Institute (CHI) Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Cambridge Healthtech Media Group, The Knowledge Foundation, and OpenHelix. http://www.chicorporate.com End
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