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Wednesday, February 8

12:00 pm Conference Registration

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

(Bridging Session between Electronic Data in Clinical Trials & Integrating and Leveraging Clinical Trial Operations Data)



Shared Session with Patient Recruitment and Retention 

1:25 Chairperson’s Remarks
Nancy Mulligan, Director, Operations, United BioSource Corporation (UBC)

1:30 To Source or Not to Source: Getting the Most from Your Internal Staff and Partners for Improved Study Start Up and Enrollment

Peter DiBiaso, Senior Director, Clinical Planning & Performance, Clinical Development Operations, Vertex Pharma

This session will examine a blended sourcing model utilized by a sponsor to optimize the planning and execution of the study site activation and start up process.


1:55 Co-Presentation - Case Study: Leveraging Organizational Data Sources to Forecast Clinical Trial Timelines

Otis Johnson, Manager, Global Trial Optimization (GTO), Merck & Co.

Ed White, Informatics Analyst, Global Trial Optimization (GTO), Merck & Co.

With the increasing constraint on resources in pharmaceutical research, it is becoming more critical to develop timely and accurate forecasts for clinical trial timelines. This reality, in conjunction with the increasing complexity of trial design, makes accurate and efficient forecasting processes a key factor in the management and allocation of limited organizational resources to execute clinical trials. Realizing this need, Merck has made a unique commitment to the forecasting and expediting of trial timelines over the past 5 years. This session will involve a discussion of forecasting for clinical trial timelines, methods and processes used to develop forecasts, and different forecasting strategies depending on when the forecast is being developed in the clinical trial timeline.

2:30 Using Investigator Focus Groups to Assess Protocol Feasibility

Lakisha Rodwell, Global Trial Optimization Specialist, Merck & Co.

2:45 Refreshment Break in the Exhibit Hall



3:10 Chairperson's Remarks
Suresh Kannan, Vice President, Product Development, DecisionView Inc.

3:15 Clinical Research Management Systems: Policies and Procedures for Achieving Compliance and Integration
Richard Scheuermann, Ph.D., Professor, Director, Division of Biomedical Informatics, University of Texas Southwestern Medical Center
Clinical research is a complex enterprise from both an operational and a legal perspective. At UT Southwestern Medical Center we have deployed a clinical research management system (CRMS) at an enterprise level with the goal of supporting the day-to-day management of clinical studies and complying with the relevant billing and reporting regulations associated with clinical research. We will discuss our experience with integrating our CRMS with the institutional eIRB system, with establishing the policies and procedures to maintain billing compliance through required budgeting and coverage analysis, and with ongoing efforts to integrate electronic data capture of standardized case report form data with our CRMS.

3:40 Leveraging and Expanding Electronic Health Data for Research
Adam Wilcox Adam Wilcox, Ph.D., Associate Professor of Biomedical Informatics Columbia University
With the increased availability of data from electronic health records, there is a desire to leverage that data for clinical research. However, there are concerns about how these data can be integrated with research data systems. We present our data integration approach with a community-centered survey and existing health record data in the WICER project at Columbia University.

Sponsored by
Pharmica Consulting
4:05 Clinical Operational Excellence

Eric Lake, Partner, Pharmica Consulting

PHARMICA specializes in operational excellence initiatives for pharmaceutical R&D organizations with a focus on project management, process improvement, SharePoint collaboration sites and clinical portals, as well as clinical data system implementation, integration, and reporting.  This presentation will include case studies illustrating how data from CROs, CTMS, IVRS, Project Server, etc. can all be integrated to provide organizations with a comprehensive, real-time view of clinical trial performance and activities; all of which were true successes for the client organizations.

4:20 - 5:30 Interactive Breakout Discussion Groups

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 more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive 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.

TABLE 22:  Clinical Data Warehouses: Are They Worth the Investment?

Steven Sweeney, Director, Clinical Technologies, Infinity Pharmaceuticals, Inc

• What is the perceived or realized business value?
• Standards implementation and the impact on warehouse management (mapping, scalability, output)
• Discuss the various consumers of warehouse data and discuss innovative ways it is being used to drive innovation, improve efficiency, etc.

TABLE 23:  Data Integration and Reporting

Moderator:  Greg Cohee, Partner, Pharmica Consulting 

• Data reporting solutions
• Clinical data system integration approaches
• Challenges and limitations with full integration

TABLE 24:  Benefits and Challenges of Integrating Electronic Health Record Data with Clinical Research Systems

Moderator:  Adam Wilcox, Ph.D., Associate Professor of Biomedical Informatics Columbia University

• Value of EHR data
• Data Issues: ccmpleteness and quality
• Successes and barriers

TABLE 25:  A Sponsor and A CRO: Bringing Data to Common Denominator

Moderator:  Munther Baara, Senior Director, Development Business Technology, Pfizer

• Data governance
• Role, experience and future of using CDISC and/or other standard models
• Methods for confirming and combining data for analysis

TABLE 26:  Data on Demand: Data Driven Monitoring Visit

Moderator:  Adrian Hsing, Senior Director, Clinical Data Management, Elan Pharmaceuticals

• Why data on demand?
• How to centralize various data
• How to utilize centrilized data to improve monitoring efficiency

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EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Clinical Research 


2012 Conference At A Glance 


Micah Lieberman 

For topic suggestions and
speaker referrals:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541-482-4709

Ilana Quigley 

For partnering and
sponsorship information:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781-972-5457

Rich Handy 

For media and association
partnerships, please

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

Signature Sponsor

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PRA Health Sciences


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