2013 Archived Content

Pre-Conference Short Courses 

Monday, February 4, 2013 • 2:00 pm - 5:30 pm • Hyatt Regency Miami • Miami, FL
Part of: Summit for Clinical Trials Operations Executives (SCOPE) 

Join your colleagues for more in-depth, focused learning at an informational and interactive Short Course. Choose one of the Short Courses below for three hours of instruction and discussion in a small group setting. Get your questions answered, network with colleagues, and share ideas.

SC2 Clinical Trial Monitoring and Compliance
SC3 Impact of the Affordable Care Act and Sunshine Act
SC4 Applying SharePoint to Clin Ops Challenges
SC5 Improving Study Start-Up


Pre-Conference Short Course 2 

Clinical Trial Monitoring and Compliance: The Role of the CRA in Supporting Subject Recruitment and Successful Study Conduct 

We will review the ever-changing role of the CRA and explore ways in which this relationship can be leveraged to maximize productivity with study sites. This workshop will provide examples of opportunities where CRAs can be more involved in all aspects of the clinical trial process. Examples include territory development, study start-up, study implementation and closeout. Participants will learn how to build and maintain the relationship between sponsor and site. Attendees of this workshop will learn:

  • Ways to partner with your sites during different phases of clinical trials
  • How to have an enrollment discussion with your site; define mutual goals and expectations
  • How to ensure ROI on territory development activities


Gretchen Goller, Senior Director, Therapeutic Expertise, Patient Access and Retention Services, PRA International

Lauren Johnson, Recruitment Manager, PRA International


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Pre-Conference Short Course 3 

Understanding and Implementation of the Affordable Care Act and Sunshine Act on Clinical Trial Management 

The Affordable Care Act includes many opportunities and pitfalls for the many systems at life science companies and clinical research organizations.  The new "sunshine provisions" in the Patient Protection and Affordable Health Care Act ("PPACA") add federal obligations to an array of requirements under state laws that regulate drug and device manufacturers' marketing to healthcare providers. The challenge for manufacturers is that state laws and the PPACA's sunshine provisions have different coverage, requirements, deadlines, allocations of expenses, formats for reporting, fees, penalties, and policies regarding the confidentiality of disclosed data. This workshop will help attendees understand the array of state requirements affecting their clinical trial operations.

  • Understand the Affordable Care Act and its implication on clinical operations
  • Review the insurance coverage and strategies to improve clinical trial enrollment
  • Analyze what is the Sunshine Act and what are the company's legal requirements?
  • Explore the opportunities in the Biosimilars FDA rules and changes in operations
  • What are first steps and strategies to become compliant with state and federal laws?
  • How can companies maintain flexibility in dealing with evolving legislation?
  • What business processes and systems are involved?
  • Implementation struggles: Centralization of all payments; FMV process and standardization and the effect
  • Change Management with Study teams: The balance of compliance and challenges of patient recruitment, site shortage


Thomas Sullivan, President, Rockpointe Corporation

Brenda Medina, Director, Global Head, Clinical Business Operations & Meeting Planning, Eisai

Marc Eigner, Partner, Polaris


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 Pre-Conference Short Course 4 

Applying SharePoint to Some of the Biggest Clinical Operations Challenges 

Almost every company in the pharmaceutical industry has SharePoint, yet almost everyone is struggling with how to maximize the value of this powerful platform. At a recent Pharmica SharePoint conference attendees expressed their struggles in three general areas: 1. Understanding what SharePoint is, 2. Understanding how SharePoint can be utilized in R&D (from both a business and super user perspective), and 3. Understanding the best way to implement SharePoint. As a result, Pharmica Consulting is jointly hosting this workshop with CHI to help the industry use SharePoint to make clinical trial personnel become more productive.

  • What SharePoint is, how to explain it, and when to use it
  • How SharePoint can be utilized in R&D (from both a business and a user perspective)
  • How to develop a basic SharePoint site for clinical trials and clinical operations
  • Best practices for SharePoint implementation
  • How other companies are using SharePoint (TMF, study and investigator portals, CRO collaboration and oversight, SOP training, CTMS Lite, study, project, and portfolio reporting capabilities, project management standards and best practices, etc.)


Matt Kiernan, Partner, Pharmica Consulting

Nick Lagrotta, Principal Informatics Consultant, Pharmica Consulting

Mark Yuzuk, Director, Collaboration & Personal Productivity, Enterprise Services, Bristol-Myers Squibb


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 Pre-Conference Short Course 5 

Developing and Implementing a Core Team Process for Efficient Sponsor-CRO-Investigative Center Communication and Rapid Study Start-Up 

Development and implementation of a "Core Team" chaired by a highly experienced clinical research investigator or staff member is vital to efficient communication and rapid start-up of clinical trials. The Core Team, supported by its staff, works together to perfect the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs. The Core Team works in direct concert with the clinical operations team from the Sponsor and/or CRO.

  • Basic Tenets of the Core Team Process as related to large clinical  programs
  • Establishing Master Confidentiality Agreements for early sharing of information
  • Role and Responsibilities of the Core Team Chairperson and Team Members
  • Pre-, During-, and Post-study implementation of Core Team Process
  • Case studies from recent programs utilizing Core Team Process


Brenda Atchison, Executive Director, Clinical Research, Alliance for Multispecialty Research

Nathan Morton, Director, Business Development, Coastal Carolina Research Center
Evette Riegel, Head, Clinical Operations, Beardsworth Consulting Group

Jeffrey Rosen, M.D., Medical Director, Clinical Research of South Florida


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