Announcing CHI’s Clinical Project Management Forum, June 2-3, 2015, Boston, MA

Managing Risk and Improving Performance in Outsourced Clinical Trials
 
NEEDHAM, Mass. - March 31, 2015 - PRLog -- Cambridge Healthtech Institute (CHI) released today the agenda for its Clinical Project Management Forum that will take place on June 2-3, 2015 at the Omni Parker House in Boston, MA, as part of the fourth annual Clinical Trial Oversight Summit where 250+ highly targeted decision makers will be in attendance.

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: Best Practices, Tools, and Techniques
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/Clinical-Project-Manag....

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

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