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Electronic Data 

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Tuesday, February 5

7:30 am Conference Registration and Morning Coffee


8:25 Chairperson's Opening Remarks

8:30 At the Intersection of Quality and Standards: CDISC is Necessary but Not Sufficient

Kit Howard, CCDM, Kestrel Consultants

With the passage of FDASIA and recent guidances, the FDA has almost all the tools it needs to require CDISC standards for all regulatory submissions. A major reason for pursuing this goal is to increase the quality of submissions, and in some respects it definitely will, but quality isn’t an automatic consequence of standards. Quality depends upon satisfying the expectations of each member of the data value chain from protocol development to regulatory submission, and that requires understanding them. This presentation will provide a very brief overview of CDISC, describe the basis for the FDA’s requirement, and discuss the quality needs that CDISC can address. CDISC has a critical role to play in clinical research, but unless it is understood by the wider development team, it risks getting the right data but the wrong answer.

OmniComm 8:55 SDTM in Practice

Keith HowellsKeith Howells, Senior Vice President, Product Development, OmniComm - Biography 

Regulatory agencies are increasingly looking for study data to be submitted in CDISC SDTM format. This sounds like it shouldn’t be too difficult, but the SDTM implementation guide runs to 300 pages, and describes 20 domains and many hundreds of variables. Figuring out how to populate one variable in one domain can easily require a day of programming. This talk describes the technical approaches and practicalities of producing SDTM output, using experience gained from doing this for over a dozen different studies.

9:20 Going Digital without Going Crazy: A Small Biotech's Total Technology Approach for a Rapid Phase III Trial

Mary Flack, Vice President, Clinical Research, NanoBio - Biography 

We describe how we implemented a Total Technology Approach, including electronic source documentation and data capture, remote monitoring, streamlined study metrics and site payment. We include comparisons between a trial run traditionally and one run with a Technology Approach. We provide lessons learned and guidance for other companies considering this approach.

Clinical Research Group 9:45 Navigating by Source Map™: An Investment in Quality Clinical Trial Data

Stephanie BergerStephanie Berger, Director, Clinical Training & Professional Development, The Clinical Research Group - Biography 

Designed as a site-level intervention, the Source Map™ system streamlines the documentation process, ensuring quality clinical trial data. Source Map™ integrates quality assurance into a consistent and precise system of documentation that produces auditable, profitable data. At every level, utilizing Source Map™ accelerates timelines while saving valuable resources.

DSP Clinical 10:00 Coffee Break in the Exhibit Hall



10:40 Chairperson's Remarks

Abraham GutmanAbraham Gutman, President & CEO, AG Mednet

10:45 Re-Use of Electronic Health Records (EHR) Based Patient Level Data by Pharma Companies: Can the Treasure Get Unveiled?

Kristin HolzapfelKirstin Holzapfel, Regional Head, Clinical Data Center Berlin; Global Data Management, Bayer Pharma AG - Biography 

Electronic health records are like treasures in the soil for pharma companies. To unveil them the European IMI (Innovative Medicines Initiative) public-private partnership project EHR4CR (EHR for Clinical Research), actively supported by Bayer Healthcare, has been initiated. Participation in clinical research on one hand, and trial feasibility by EHR data re-use on the other hand, are strong drivers for alignment of healthcare institutions, patients, EHR providers and Pharma companies. A snapshot of the project’s progress will provide some insight into the approaches being taken to tackle many of the challenges that have already surfaced during the first phase of the project.

11:10 Re-Use of EHR Data and Task-Dependence of Data Quality

Nicole WeiskopfNicole Weiskopf, Department of Biomedical Informatics, Columbia University - Biography 

Interest in using electronic health record data for clinical and translational research, quality of care metrics, and public health surveillance has led to a complex question: Are these data of sufficient quality for re-use? In our research, we demonstrate that data quality findings are task dependent. The number of useful patient records varies widely depending upon the intended use of the data and the methods used to evaluate quality.

ERT 11:35 Beyond ePRO: Capturing Electronic Clinical Outcome Assessments (eCOAs)

Jean PatyJean Paty, Chief Scientific & Regulatory Advisor, ePRO Solutions, ERT - Biography 

In October of 2011, the FDA stated that it was going to expect that all outcomes, not just PROs (Patient Reported Outcomes), need to meet FDA expectations as outlined in the FDA PRO Guidance. These other COAs include Clinician Reported Outcomes (ClinROs) and Observer Reported Outcomes (ObsROs). This statement from the FDA has already begun a trend toward the capture of all COAs electronically (i.e. eCOAs). This presentation will summarize the wide array of ePRO systems and how they are quickly being applied to other COAs.

12:00 pm Lunch on Your Own


Shared Session between Electronic Data in Clinical Trials and Strategic Alliances

1:25 Chairperson's Remarks

Keith HowellsKeith Howells, Senior Vice President, Product Development, OmniComm - Biography 

1:30 Featured Presentation: Integrated Data Environment for Clinical Trials

Munther BaaraMunther Baara, Senior Director, Development Business Technology, Pfizer - Biography 

In 2011, Pfizer made a dramatic change in the way they operate in clinical development, by outsourcing the majority of their clinical development departments to two strategic CROs (or Alliance Partners). In parallel to, and to enable, this industry changing shift in their operating model Pfizer is embarking on a radical technology move that we'll see their clinical data being hosted in the cloud. The backbone of this cloud based utility model is the Oracle Health Sciences Cloud along with many Oracle Health Sciences applications such as Oracle LSH as the data warehousing back-bone for the Clinical and Scientific Data Warehouse (CSDW) and the Operational Data Warehouse (ODW), Oracle CDA as the Operational Data Model and Reporting Layer, and Oracle Fusion Middleware as the Information Exchange Hub (IXH). The aim of this presentation is to take you through the journey Pfizer is going through to enable this shifting operating model and building out the Clinical Aggregation Layer (CAL) as a Cloud-based utility platform.

1:55 Developing and Managing Clinical Data Standards in an Outsourced Model

Paul Bukowiec, Director, Oncology Standards Management, Millennium: The Takeda Oncology Company - Biography 

This presentation will highlight opportunities and challenges encountered when developing a clinical data standards strategy in an outsourced model. The focus will be on outsourcing under a preferred provider model. Attention will be given to alignment of sponsor and vendor strategies as well as utilization of industry standards.

PharmaPros 2:20 The Impact of Analytics: Transforming Clinical Trials Data into Business Intelligence

 Brion ReganBrion Regan, Head, Strategic Development, PharmaPros CorporationLife sciences organizations are seeking new ways to access the intelligence residing in their clinical trials data. A critical first step in this effort is the need to centralize information in an automated way. With a hub where trialdata can be aggregated and stored commonly, organizations can leverage analytics for a wide variety of applications. From feasibility analysis of trial design and site selection, to modeling risk factors for source data verification, analytics can transform clinical trials data into powerful business intelligence.

2:35 Panel Discussion: Integrating and Managing Data in Multi-Company Partnerships

Moderator: Keith Howells, Senior Vice President, Product Development, OmniComm

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

Paul Bukowiec, Director, Oncology Standards Management, Millennium: The Takeda Oncology Company

Keith Wenzel, Senior Director, Global Alliances, Perceptive Informatics 

  • Real-time access to data in an outsourced trial
  • Sponsor's control of clinical data
  • Clinical data standards strategy

DSP Clinical3:00 Refreshment Break in the Exhibit Hall


AG Mednet 3:40 Is Zero Delay Achievable in the Clinical Trial Process?

Abraham GutmanAbraham Gutman, President & CEO, AG Mednet - Biography 

Is a zero delay world achievable in the image intensive clinical trial process? Join a discussion around current obstacles in clinical trials, especially data quality and compliance challenges. Innovative technology advances allow the industry to expedite and automate processes along the sponsor/principal investigator/core lab continuum resulting in more successful trial outcomes.

4:05 Clinical Documentation and Study Report Publishing in a Structured Content Management Environment

Joan AffleckJoan Affleck, Senior Director, Clinical Documentation, Sanofi - Biography 

In order to achieve higher levels of efficiencies, consistency and quality of information across the clinical planning and documentation processes, Sanofi developed a business case and program to implement a topic-based Structured Content Management (SCM) solution framework. The approach was to leverage best-of-breed technologies and industry standards to implement a solution framework that could be utilized to implement SCM to incrementally address content and documentation deliverables across the entire product development life cycle and deliver business value.

4:30 Interactive Breakout Discussion Groups 

Table: A Sponsor and A CRO: Bringing Data to Common DenominatorModerator: 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 Moderator

TABLE: Data Integration for Increased Clinical Trial EfficiencyModerator: Mary Flack, Vice President, Clinical Research, NanoBio• Defining data integration and the total technology approach
• Advantages and hurdles to data integration in clinical trials
• What’s next in clinical trial data integration or “Is the completely paperless trial possible?”

TABLE: Utilization of EHR data in Clinical Research: Overcoming Regulatory, Policy, Technical, and Organizational ChallengesModerator: Nicole Weiskopf, Department of Biomedical Informatics, Columbia University• Patient privacy: HIPAA, HITECH, protected health information (PHI), and "safe harbor" data.
• Data suitability: the quality, fidelity, appropriateness, and usability of EHR data.
• Data governance: organizational and institutional barriers to EHR data reuse.

TABLE: What are you doing about risk-based monitoring?Moderator: Keith Howells, Senior Vice President, Product Development, OmniComm Systems• Participants will be asked to share their plans and/or actual experiences with risk-based monitoring, based on the FDA’s recent draft guidance. Bullet
• We shall also discuss what advances are available in EDC products to easily support this new business requirement.  


5:30 Welcome Reception in the Exhibit Hall

6:30 End of Day

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