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The effects of globalization, social media, and risk-based approaches to clinical trials have had a profound effect on project managers. Barnett International/CHI's fifth annual Clinical Project Management Forum will address the many responsibilities of clinical project managers, and evolving issues such as ensuring the delivery of high quality and highly valuable data, improving performance, optimizing patient recruitment, mitigating risk, and navigating the various challenges and opportunities of global clinical trials. Participants will benefit from case studies, take-away tools, perspectives on the current regulatory environment, breakout groups, and interactive activities.


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Wednesday, June 4, 2014

7:00 am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks



CASE STUDY! 8:15 Risk Management and Implementation of Strategic Project Management Tools in Clinical Trials

Marina Malikova, Ph.D., CCRA, MA Clinical Investigation Executive Director, Surgical Translational Research Operations and Compliance, Boston University

At Boston University, we have analyzed clinical trials testing fibroblast cell based agents. These studies have similar objectives, study design, inclusion/exclusion criteria, and outcomes of biological trials. We have attempted to develop and implement strategic management tools in order to improve performance and compliance. We have developed and implemented project management tools such as Schedule Performance Index (SPI) and Cost Performance Index (CPI) that yielded higher enrollment and better compliance rates. Also, we performed risk assessment and Cause-Effect Analysis which allowed us to accelerate start-up activities, and increase compliance and efficiency during the execution phase. After this session, participants will be able to explain concepts of strategic management tools, design a risk management plan, perform Cause-Effect Analysis, calculate schedule performance and cost performance index, assess efficiency of clinical trials, and improve performance and compliance.

CASE STUDY! 9:00 Mitigating Clinical Study Risks Utilizing a Robust Catalog of Targeted Reports

Rosanne Petros, Clinical Project Manager US, Global Clinical Trial Operations–The Americas, Merck Research Laboratories

In an effort to include those study sites with the greatest chance of success, Merck has developed metrics reports showing cycle times for many factors related to site readiness: IRB submission and approval, contracting, and first subject enrolled. In addition, the metrics include variances between anticipated and actual subjects screened and enrolled, as well as a comparison of site versus overall screen failure and discontinuation rates. Once sites are selected, we continue to monitor site ready data with another group of targeted reports. These reports track planned, latest estimate, and actual dates for study start up activities, focusing on outliers which could trigger potential timeline slippage. After site ready milestones are met, we focus on site recruitment and retention, including indicators surrounding potential patient risk. Using a risk-based model, monitors visit sites based upon factors such as number of subjects enrolled, subjects ongoing, subjects screened, number and type of protocol deviations, and site issues such as site staff turnover.

9:45 Coffee Break and Exhibit Viewing

10:15 Coverage Analysis, Budgeting, and Pre-Award Practices Limiting Fiscal Risk in Clinical Research

Erika Stevens, Senior Manager, Advisory Services Health Care, Ernst and Young LLP

This session identifies pre-award processes and institutional approaches to increasing fiscal return and mitigating fiscal compliance risk for clinical trials. The ability to develop robust budgets and ensure billing compliance for clinical trials is a challenge for many sites. Furthermore, guaranteeing adherence to CMS regulations can be a struggle. Poor fiscal forecasting and undefined billing compliance practices associated with clinical trials increases the risk of deficits and OIG investigations. This session describes the strategies for covering true costs related to clinical trials research, illustrates techniques for avoiding false claims, and evaluates case studies. Participants will be able to:

  • Describe the processes for fiscal oversight of clinical trials research
  • Recognize key tools for managing fiscal/regulatory activities
  • Apply leading practice to coverage analysis oversight

11:00 Interactive Roundtable Discussions

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own



1:00 pm A Holistic Approach to Managing Clinical Trials

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

In 2011, FDA and EMA each published papers on risk-based approaches to managing clinical studies. FDA focused directly on monitoring as such; EMA’s publication reviews clinical development and how a risk-based approach can help overcome current issues. Many sponsors have embarked on this new course, but many are struggling to complete the change. There are some essential questions that need to be answered:

  • Why do sponsors face difficulties when implementing a risk-based approach?
  • How can we overcome these difficulties? What are the key elements that need to be considered?
  • How come most of the sponsors cannot realize the cost saving potential that RBM promises? What needs to be done to make it happen?
  • Focusing where it really matters, how can we detect real quality improvements?

1:45 Remote Control: Managing Teams You Rarely See

Stephanie J. Zafonte MSN, RN, CCRP, Nurse Consultant/Clinical Project Manager, EHDB/DMID, NIAID, NIH, DHHS



2:30 Multi-National Clinical Studies: The Good, The Bad, and The Ugly

Kenneth K. Kleinhenz, Vice President, Global Regulatory Affairs, Cytori Therapeutics, Inc.

Multi-national clinical studies are frequently utilized as a means to expedite study enrollment and involve influential multi-center institutions, leading to high-quality publications and investigator podium presentations that facilitate early commercial credibility. Depending on the nature of the medical product to be studied, careful consideration must be given to which countries are chosen for multi-national studies. When complex and innovative medical products are involved, we must consider all aspects of the multi-national strategy, including regulatory history, structure, leadership, burden, and credibility, as well as potential patient population and the primary language of the prospective clinical trial country. This presentation will address the pros and cons of common clinical trial countries, and share practical experiences with a novel medical device that processes adult stem cells in the same surgical procedure.

3:15 Sponsored Presentation (Opportunity Available)

3:30 Refreshment Break and Exhibit Viewing

3:50 Strategies for Success in Emerging Markets

Mauro Martinelli, Associate Director, Emerging Markets Specialist, Clinical Development, Quintiles

Emerging Markets are increasing their relevance in global clinical trials, especially as some of them are becoming strategic from a commercial point of view, supported mainly, by significant development of a middle class demanding more and better medications, paired to an increased prevalence of typical diseases of the Western World. Such is the case of Brazil, and to a certain extent, of Mexico and Argentina. Governments are increasing their expenditure in healthcare, while industry is trying to reduce cost. Focusing attention on where to allocate enrollment is a key factor. Companies that have seldom worked outside the US and EU will need to assess other markets, and Latin America has a key role in this regard.

CASE STUDY! 4:35 Overcoming the Challenges in Global Clinical Trials: A Clinical Trial in Asia

Larn Hwang, Ph.D., Vice President Regulatory & Clinical Operations, Sorrento Therapeutics Inc.

Trials in Asia are becoming increasingly popular with the growing number of competing trials in US/EU. Asia trials are expected to be faster to set up, more rapid regulatory submission, quicker patient enrollment rate, and lower study costs. We would like to share our experience in conducting oncology trials in Singapore and Malaysia. The hurdles and advantages of these trials will be presented. The regulatory framework of each country will also be addressed. We will compare and contrast oncology trials between the US, EU, and Asia.

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

6:20 Close of Day One


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