Cambridge Healthtech Institute’s Sixth Annual
Electronic Data in Clinical Trials
Collecting and Leveraging Data to Optimize Clinical Trials
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL
The entire clinical trial process is becoming more and more data driven. From study design to recruitment and trail management, to data analysis and publication of a study manuscript, we are dealing with data, and the overall result of a study very much depends on how well we manage it. This trend is escalating because of the rapid development and optimization of electronic health records and health care IT in general. CHI’s 6th Annual “Electronic Data in Clinical Trials” is designed to feature the latest trends in clinical trials data management. It will bring together clinical IT experts and their colleagues from clinical development departments to discuss system approach to data management in the era of new medical data landscape.
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Mon February 3 See all Short Courses
TUESDAY, FEBRUARY 4
7:00 am Registration and Morning Coffee
8:00 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
8:05 Chairperson’s Opening Remarks
Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP
8:15 Plenary Keynote Introduction
Nancy Mulligan, Senior Director, Operations, Patient & Physician Services,
United BioSource Corporation
8:20 Plenary Keynotes and Panel
What Does a Trial Mean in the Era of Real-Time Measurement?
Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe
The Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer”
Christine Pierre, President, The Society for Clinical Research Sites (SCRS)
PANEL: Perspectives from a Cast of Characters Needed for Any Successful Study Execution
9:45 Grand Opening Coffee Break in the Exhibit Hall
10:45 Chairperson’s Remarks
Kirstin Holzapfel, Deputy Director, Global Clinical Data Center, Bayer / Global Clinical Operations
10:55 KEYNOTE PRESENTATION: Challenges and Opportunities in Building a Foundation System for the New Medical Data Landscape
Francis Kendall, Global Head, Statistical Programming and Analysis, GLIDE Future Investigation Team Lead, Genentech
This talk will look at the challenges and opportunities the new Medical data Landscape for Pharma brings and how Roche are setting the foundation with implement a new systems.
11:20 Development of a Scientific Decision Support Framework across Clinical Development
Paul Konstant, Manager, Translational Informatics, Janssen Pharmaceutical Co.
Scientific decision support presents an ongoing challenge to balance processes with flexibility. This presentation will describe a framework for integrating experimental outcomes being applied at Janssen. Through examples of technology implementations and scientific analyses, this presentation will show how scientific context can be leveraged to meet the diverse needs of clinical development.
11:45 The Use of CRUISE, a Structured Content Management System, to Maximize the Value Realized from Clinical Study Documents
Michael Jasper, Ph.D., Director, Clinical Documentation, Genzyme, a Sanofi Company
The CRUISE (Content Re-Use Information System for e-Health) Program is a topic-based structured content management system being developed at Sanofi. The presentation will focus on the use of Topic Maps, Content Libraries and Metadata to maximize re-use potential and efficiency of clinical document production and improve content standardization within an organization as well as harmonize document structure and content with emerging industry standards.
12:10 pm What Will Clinical Data Applications Look Like in Five Years
Keith Howells, Senior Vice President, Development, OmniComm Systems, Inc.
The technology landscape is changing quickly, with more data captured electronically at source, an explosion of mobile applications, and an increasing ability for related applications to share data in real time. Similarly there have been surprising new initiatives in regulatory guidance, notably for eSource and risk-based monitoring. This presentation will explore how the market for eClinical applications is likely to evolve to take advantage of these exciting trends.
12:35 Luncheon Presentation: Risk-Based Monitoring and eSource – 2 Sides of the Same Coin
Edward S. Seguine, CEO, Clinical Ink
Risk-Based Monitoring and eSource are complementary and interdependent approaches that, when implemented together, can fundamentally transform existing business practices beyond what is possible if either approach is adopted singly. This presentation will summarize experiences across 40+ studies in a range of study types to identify common issues and specific benefits.
1:15 End of Morning Session
1:25 Chairperson’s Remarks
Nancy Mulligan, Director, Operations, Patient & Physician Services, UBC
1:35 Clinical Genomic Data Integration and Clinical Trials
Jomol Mathew, Ph.D, Director, Clinical and Translational Informatics, IS,
Dana-Farber Cancer Institute
We present a strategy, systems and tools that we have developed at Dana-Farber Cancer Institute in integrating clinical genomic data for enabling translational research, clinical trial matching and cohort identification.
2:00 Towards Precision Design of Clinical Trial Eligibility Criteria Using Electronic Health Record
Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics, Columbia University
I will propose approaches to enable transparent, evidence-based precision design of clinical research eligibility criteria that allow rapid feasibility assessment and testing of research generalizability and clinical effectiveness in silico. I envision that the new “precision design” will allow clinical researchers to articulate their rationale for defining clinical trial eligibility criteria (e.g., how was the value of each criterion chosen?).
2:25 Leveraging EHR Infrastructure and Process for Trial Participant Identification, Enrollment and Retention
Les Jebson, Executive Director, Diabetes Center of Excellence, University of Florida Academic Health Center
With broad implementation of comprehensive EHR systems, the ability for brisk data mining and eligible trial participants in an emerging tool for organized research. However, there are key logistical and legal process steps which must be adhered. This presentation walks participants through the essential process steps for efficient and comprehensive participant identification, enrollment and retention through the EHR platform.
2:50 Data Management Re-Mix: The Need for New Tools, Technologies and Terminologies
Subha Krishnan, CCDM Principal Data Manager, Optum
Late Phase studies have become a thriving segment of pharmaceutical research in recent years and data management processes have evolved to support them. Given the global nature of these studies and cultural considerations, long durations, varying internet availability, these studies can be set up as paper only, EDC only, or a hybrid approach. In this presentation we explore various approached to data capture while keeping in mind the cost, efficiency and needs of the study.
3:05 Refreshment Break in the Exhibit Hall
4:05 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
CLICK HERE to view the current topics and moderators
5:15 Welcome Reception in the Exhibit Hall
6:15 End of Day
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