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Follow on Google News | Announcing CHI’s Vendor Management in Clinical Trials Conference, June 1-2, 2015, BostonEnsuring Data Quality through Effective Selection, Auditing, and Oversight
Agenda at-a-Glance: Monday, June 1 Clinical Trial Vendor Selection: Selecting the Right CRO Strategic Partner Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC) Re-Engineering the RFP and Bid Defense Meeting Manage Risk and Quality Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc. Establishing a Strong Communication Channel with Your Third Party Vendor Nicole Yingst, MBA, CCRP, Patient Recruitment Specialist II, PAREXEL International Case Study: Successful Collaboration and Merging of Multiple Vendors Within an FSP Erika Vento, MBA, Clinical Trials Oversight Manager (CTOM), Amgen Inc. Effective CRO Oversight in a Strategic Outsourcing Model Joe Pollarine, Director Quality Monitoring & Compliance - Bioresearch Q&C, Janssen R&D – Springhouse US Case Study: Lessons Learned in Developing a Metrics Program to Monitor the TMF at a Vendor Vinita Leslie, M.A., Director, Trial Master File Process Owner, Knowledge, Records & Information Strategies, Biogen Idec How Will Risk-Based Monitoring Change Your Relationship with Your CROs Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd. Case Study: Managing Quality in an FSP Monitoring Model Erik Olson, MPH, Clinical Trials Oversight Manager (CTOM), Amgen Inc. Dinner Course: Facilitating Investigative Sites’ Operational Efficiency: Challenges, Tools, and Methods to Enhance the Clinical Research Enterprise Tuesday, June 2 Adopting Standardized Time, Quality, and Efficiency Performance Metrics Across Your Vendors Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC) Using Performance Metrics to Manage Vendors in 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 Using Warning Letters to Prepare for BIMO Inspections Valerie Rosemond, Quality Assurance, Johnson & Johnson Vision Care Case Study: Managing Risks During Project Transition: Person to Person, Team to Team, Sponsor to Vendor, and Vendor to Vendor Donelle Bussom, RN, MSN, Senior Director, Medical and Safety Services, ICON Clinical Research Sponsor Oversight: The Importance of Auditing in Vendor Management Beverly Brown, Manager, Global Regulatory Quality, Allergan Dinner Course: Quality by Design in Clinical Research: Is This Only for the Protocol? 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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