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Barnett International & Cambridge Healthtech Institute's fourth annual Clinical Project Management Forum will feature case studies, lessons learned, and presentations from industry project management thought leaders. Clinical Project Managers have many responsibilities: ensuring the delivery of high quality and highly valuable data, optimizing performance, mitigating risk, and navigating the various challenges and opportunities of global clinical trials. This conference will provide attendees with practical techniques for maximizing resources, optimizing project performance and trial outcomes, and developing world-class clinical project management skills within themselves and others.
Don’t Miss the Pre-Conference Dinner Short Course*:
Proactive Approaches to Vendor Management
Wednesday, October 10 (5:30 pm - 8:00 pm)
Michael J. Harte, Founder and President, The Harte Group
View course details
*Separate registration is required
Thursday, October 11
7:30 am Breakfast Presentation - Models for Managing Global Clinical Trials: Challenges, Opportunities, and Regulatory Considerations
Cellia K. Habita, M.D., Ph.D., President & CEO, Arianne Corporation
The past few years have witnessed a significant increase toward geographic expansion in conducting clinical trials. It has become routine to target regions in E. Europe, Asia and Africa. These areas allow the recruitment of large patient populations that are no longer available in the USA. For clinical research teams, these opportunities require that cultural and language barriers need to be overcome while working with challenging regulatory environments and adhering to good clinical practice guidelines.
8:30 Barnett Welcome and Introductions
8:35 Chairperson’s Welcome and Opening Remarks
8:45 Outsourcing Trends and Their Effects on Project Management
Adam Chasse, Vice President, Corporate Development, RxTrials, Inc.
As industry attempts to decrease timelines and lower costs, a variety of non-traditional outsourcing is beginning to occur. The days of the straightforward Sponsor-CRO-Site supply chain are dwindling as niche providers rise in prominence and CROs themselves often need to outsource in order to keep up with demand borne by their strategic alliances with sponsors. This session will identify current outsourcing trends, forecast the 3-5 year evolution of outsourcing, and examine how project managers will need to alter their approaches to ensure success in an increasingly complex vendor environment. The audience will come away with an appreciation for the increasingly complex web of vendors, and what knowledge and skills they will need to develop in order to succeed as project managers.
9:30 Best Practices for Managing Clinical Resources Organizations (CROs) and Strategic Partners
Tina Karunaratne, Clinical Project Manager, Clinical Operations, Vertex Pharmaceuticals
10:15 Coffee Break with Exhibit Viewing
10:45 Nurturing and Maximizing Potential of High Performing Clinical Staff
Eric Morfin, MBA, PMP Partner, Clinical Excellence Research Institute; Partner, Critical Skills, Inc.
This session will address the question, “What drives high performers?” Your speaker will describe how to:
• Design a performance environment that motivates all through clear expectations and consequences
• Mitigate and effectively manage potential risks, and apply a systematic method to prevent potential delays
• Recognize clinical staff personal drivers and use them to influence site personnel and investigators to meet and exceed your expectations
• Identify proven processes for influencing and coaching others toward excellence
11:30 Systems Theory and Thinking: An Important Critical Skill Set for Successful Clinical Project Management
Manley R. Finch, Ph.D., Dr.PH(c), MPH, Medical Affairs, South East USA, GTC Biotherapeutics, Inc.
and Executive Director, HIV Nutrition Network, NPO
This session will provide attendees with a brief overview of the concept and history; a review of how clinical trial programs and projects are complex systems and require Systems Thinking; how to successfully understand, manage, and design complex systems using Systems Thinking; direct application of Systems Thinking to clinical trial program and project management; why programs and projects derail and how to prevent this with Systems Thinking; and how Systems Thinking creates immediate ROI to you, your team, and your employer. This session will help attendees gain a working knowledge of how to:
• Apply Systems Thinking to clinical program and project management to ensure successful team oriented goal accomplishment
• Successfully understand, manage, and create complex systems that work using Systems Thinking
• Prevent program and project derailment using Systems Thinking
12:15 pm Sponsored Presentation (Opportunity Available; contact Ilana Quigley, firstname.lastname@example.org)
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30 Improving Trial Workflows and Collaboration with the Cloud: How NCI and Research Partners are Using Interoperable Digital Identities, Digital Signatures, and Cloud Computing to Improve Trial Start-Up
Gary Secrest, CTO and Vice Chairman, SAFE-BioPharma Association
The session will discuss an ongoing study involving government (NCI) and industry (Bristol-Myers Squibb, sanofi-aventis) cancer researchers showing how use of interoperable digital identities, digital signatures and cloud computing accelerates initiation of a clinical trial while lowering its costs. Researchers were provisioned with interoperable U.S. Government and SAFE-BioPharma digital identity credentials, which were used to access, amend, sign and exchange electronic documents placed in the cloud. Prior to the study, the process was delayed by use of courier, fax, travel, etc. NCI has developed impressive ROI figures which will be part of the presentation. The audience will come to understand:
• Why and how standards-based interoperable digital identities facilitate more effective and economical study start up
• How to start a clinical trial substituting cloud computing and digital signatures for paper forms
• The unique role of digital signatures in protecting confidential patient information
2:45 Project Management in the Electronic Environment: EDC and EMRs
Leslie Humphries, MT, CCRA, Head of Clinical Operations, Merz Pharmaceuticals, LLC
Researchers are facing potentially huge challenges maintaining compliance and adhering to regulations with EMR systems that were not developed for research. Creating regulatory compliant source as well as monitoring in the electronic environment is a new challenge. Sponsors, CROs, and CRAs are struggling to develop training for solid methods of monitoring within EDC and EMRs. Site coordinators also want to know what to do to meet the requirements for what monitors need. Attendees will learn about aspects of EMR systems and how they should be utilized and monitored within the research environment. They also will learn how to improve the efficiency and effectiveness of onsite and remote monitoring in EDC systems. This talk focuses on both basic EMR system compliance and source documentation requirements. It also provides tips for effective monitoring in these systems. We will discuss the most common issues of EMR systems and offer guidance on how to resolve these issues. We also will cover effective monitoring techniques in EDC, including remote monitoring and remote query resolution.
3:30 Refreshment Break with Exhibit Viewing
3:45 Models for Managing Global Clinical Trials
Adam Ruskin, D.V.M., Ph.D., MPH, Director of Clinical Affairs, GenturaDx, Inc.
How are you going to manage a global Phase II or III, or multiple global trials, out of your 2-3 person clinical department? Strategies for selecting the right countries, the most appropriate vendors, and how to stay on top of all of the day-to-day activities can permit very efficient management. Knowing the regulatory timelines and restrictions, where compliant sites are located, and per-site costs and enrollment projections relative to the US can guide your decisions. Challenges including global laboratory sample tracking, start-up timelines, and vendor oversight, as well as the opportunities to decrease your costs and improve data quality will be discussed. As someone who has managed many successful concurrent trials, from both the sponsor and CRO perspectives, some real insight will be provided.
4:30 Developing Resourcing Models for Clinical Studies and Regulatory Affairs
Mariana Tran, Program Manager, Otsuka Pharmaceutical Development & Commercialization, Inc.
David Goldberger, Senior Director Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc.
Developing an accurate and complete resourcing plan is a key factor for successful clinical trials and regulatory submissions. In this presentation, the presenters will discuss Excel- and MS Project-based models that can be considered for clinical trial and submission resource planning. In addition, the presentation will highlight steps that need to be taken to assess what model can be selected for your organization and how to gain model endorsement. Based on the presenters’ experience, a general timeline for the endorsement, development, and implementation of resource planning process and systems will also be discussed.
5:15 Networking Reception with Exhibit Viewing
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