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The fifth annual Mastering Clinical Trial Monitoring conference will focus exclusively on the changing landscape and evolving role of clinical trial monitors. This event will bring together thought leaders to share their experiences and insights related to the industry’s most topical issues such as the FDA’s Final Guidance on Risk-Based Monitoring, the impact of TransCelerate’s efforts in the industry, monitoring international clinical trials, and quality systems-based approaches to monitoring. Participants can expect case studies, hands-on activities, and take-away tools that will enhance their monitoring experiences and expand their monitoring expertise.


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Monday, June 2, 2014

7:00 am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks

Chairperson - Gail Fowler, Vice President, Operations, Rho



8:15 The Brave New World of Risk-Based Monitoring

Susan Bosworth-Farrell, BSNMPH, CCRC, CCRP, Clinical Operations, Senior Clinical Research Associate, Abbott Vascular

We have entered a brave new world of monitoring with the FDA final guidance on risk-based monitoring. In an attempt to capture a “snapshot in time” of how both CRAs and CRCs perceiving and are adapting to “remote monitoring” processes, your speaker and a colleague developed a questionnaire for CRAs and CRCs. The results of the survey and a discussion of its implications and recommendations are presented here in an attempt to understand how the guidance is being implemented and utilized from both the site and sponsor/CRO perspectives. This survey and the responses it elicited from a range of clinical research professionals provides much insight as to how the process of remote monitoring is being implemented and received at this point in time when new monitoring paradigms are being introduced.

CASE STUDY!  9:00 Challenges and Solutions to Implementing a Risk-Based Monitoring Program within an Academic Research Institute

Gregory Staios, Research Monitor, Research Services, Centre for Addiction and Mental Health

Monitoring is an activity that has historically been neglected within academic research institutes for a multitude of reasons, including a lack of resources. The utilization of risk-based monitoring approaches has allowed for more tailored approaches for monitoring investigator initiated studies that are proportional to study related risk, thus potentially decreasing resources necessary to institute a monitoring program. Recently, our organization, Canada’s largest mental health and addiction hospital, has instituted a variety of measures to undertake monitoring of regulated IIS. These include conducting study specific risk assessments, creating monitoring plans, stratifying who will conduct monitoring based on risk, and creating an education and mentorship program for team based monitors. This presentation will provide attendees with a framework for implementation of such programs within their institution.

9:45 Coffee Break and Exhibit Viewing

10:15 Implementing Risk-Based Monitoring: A CRO perspective

Ben Dudley, Executive Director, Alliance Management, Clinical Development Services, Covance, Inc.

This presentation will address the challenges, opportunities, and impacts of risk-based monitoring (RBM) both in theory and as implemented on real-life projects. Drawing on the first-hand experience of the speaker, the audience will hear about how different perspectives on RBM impact expectations. This presentation also explores barriers to RBM implementation, and how working in partnership allows a more clear opportunity to investigate and articulate these issues with stakeholders.



11:00 ACRES: A Global Systems Approach to Enhancing Clinical Trial Quality, Safety, and Efficiency

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

The Alliance for Clinical Research Excellence and Safety (ACRES) includes global leaders and organizations from the entire clinical research/clinical trials enterprise. Their goal is to provide comprehensive integrated systems-solutions to the many challenges facing clinical research by collaboratively building an open, shared, global infrastructure that benefits all stakeholders while aligning ethical principles with good business and scientific practices. In this presentation, your speaker will discuss ACRES’ various initiatives: Site Accreditation Standards, Site-Optics and Quality Informatics, Quality and Safety Initiatives, Product Safety Culture Initiatives, and Global Ethics and Regulatory Innovation.

11:45 Realizing the Promise of Cost Reduction in Clinical Trial Monitoring Through Emerging Technologies

Harshal Shah, Director, Life Sciences & Healthcare, Persistent Systems Ltd

The talk will focus on the impact of SMAC technologies (social, mobility, analytics and mobility) to improve clinical trial monitoring . Illustrative uses cases showcasing the potential to leverage the data available  at various stages of the process thereby  achieving quality and efficiency, cutting costs along the way.

12:00 Luncheon Presentation - Virtual Site Visits: A Powerful Complement to RBM

Bill Cooney, President and CEO, MedPoint Digital

Virtual Site Visits (VSV) are a powerful yet under-utilized component of site monitoring. New technologies enable monitors and sites to collaborate in real time and perform most or all of the activities of an on-site visit. VSVs can significantly lower cost, improve productivity and enhance quality, while enhancing personal relationships with sites. Attendees will gain understanding of the versatile capabilities of VSVs and how VSVs can effectively complement any RBM program.

1:00 pm Piloting Risk-Based Monitoring: A TransCelerate Member Company Perspective

Ramil Abdrachitov, Clinical Research Director, Clinical Operations, AstraZeneca

This presentation reflects first-hand experience from piloting Risk-Based Monitoring using the methodology developed by TransCelerate. It will guide the audience on important aspects which should be considered implementing RBM. Your speaker will share the experience of AstraZeneca from the ongoing Risk-Based Monitoring pilot study. AstraZeneca’s approach to risk assessment, monitoring plan preparation, SDV, and Source Document Review will be described, as well as the feedback from FDA on RBM-related documents. The place and scope of centralized data monitoring, and the division of responsibilities among central, remote, and on-site monitoring will be discussed. Participants will gain from lessons learnt and initial results. This session will help participants implement RBM faster and smarter, and avoid some mistakes. Sharing and discussion of practical experience will facilitate evolution of RBM methodology.

1:45 FDA Investigation Preparation: The Dos and Don’ts

Nancy S. Bakke, Manager, US Clinical Monitoring, Sorin Group CRM and Cardiac Surgery

This presentation provides a step-by-step guide for clinical research sites to understand the inspection process and how to prepare for it. Participants will gain a better understanding of investigator roles, investigation objectives, and investigation preparation for sites and sponsors. The details for developing training plans will be provided. Participants will be given a practical list of inspection do’s and don’t’s. End of inspection details will be discussed, including FDA process, responding to 483s, suggestions for addressing 483 observations, common FDA findings, and FDA responses. This session provides a tactical, practical guide for sites.

CASE STUDY!  2:30 Institutional Risk-Based Monitoring: Three Years Later

Ina Abel, Manager, Clinical Research Monitoring, St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital deployed our method of risk-based monitoring in 2010, putting them ahead of the RBM curve. The original institutional monitoring plan was beneficial in many ways, yet caused push back by Principal Investigators, stretched the monitoring resources thin, and occasionally confused priorities. Implementation of a risk-based monitoring plan required patience, planning, a staged roll-out, and strategic communication. Initially criteria were developed for four main risk categories. Open studies were ranked by perceived and calculated risks. For new trials, study risk was determined by monitoring management and study-specific monitoring plans were developed with Principal Investigator input. After three years, virtually all studies are now monitored according to the more focused, risk-based institutional monitoring plan. Participants will learn from St. Jude’s challenges and successes.

3:15 Risk-Based Monitoring of Clinical Trials Using JMP Clinical

Richard C. Zink, Ph.D., Principal Research Statistician Developer, JMP Life Sciences, SAS Institute Inc., JMP Division

Risk-based monitoring (RBM) makes use of central computerized review of clinical trial data to determine if sites should receive more extensive quality review through onsite monitoring. I’ll demonstrate an RBM solution in JMP Clinical to assess data quality. Data from patients who experienced an aneurysmal subarachnoid hemorrhage will provide illustration.

3:30 Refreshment Break and Exhibit Viewing

3:50 What’s the Difference? Pharma vs. Device Studies

Eddy Lyons, CCRP, Senior Clinical Research Associate, Biotronik, Inc.

Differences between drug and device studies are driven by regulatory definitions, manufacturing processes, and development pathways. Such differences have a direct impact on the lifecycle of the research-to-market process, including how new products are reviewed by regulatory authorities, how protocols are constructed, and how IRBs determine subject informed consent. This talk will highlight the differences between these two types of research. Discussion will include the differences in the Investigational Device Exemption (IDE) regulations versus Investigational New Drug (IND) regulations, marketing timelines, IRB review, and documentation requirements.



4:35 Cultural and Socioeconomic Variables in Global Clinical Trials and Their Effect on Risk-Based Monitoring

Vlad Bogin, M.D., CEO, Clinical Research, Cromos Pharma

Risk-based management plans in international trials have to be carefully tailored to local environments. Cultural and socioeconomic domains are extremely important, and failure to factor them in may result in poor data quality and compliance. The newly proposed risk-based monitoring may meet significant logistical challenges if these issues are not considered very early in study design.

5:20 Welcome Reception and Exhibit Viewing (Sponsorship Opportunity Available)

6:20 Close of Day One


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