Archived Content

Clinops Data Integration 

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Wednesday, February 6

11:30 am Conference Registration

12:05 pm Lunch on Your Own


1:25 Chairperson's Remarks

Gary Kennedy, Founder and CEO, Remedy Informatics - Biography 

1:30 Featured Presentation: Smarter, Faster Clinical Development: A platform based approach

Marc Raman, Executive Director, IT Strategy Office, Merck - Biography
This presentation will cover the topic of leveraging an integrated end-to-end technology platform, and using a standard catalog of value dials to 1) simplify and accelerate decision making through the use of a standard Governance and portfolio prioritization mechanism, 2) accelerate time to market of technology solutions that drive Clinical end-user productivity, and 3) enable strategic vendor partnerships, through improved ease of doing business.

1:55 Data Warehouses: Cornerstone for a Medical Information Platform Designed for an Outsourced Environment

Greg Moody, Chief Technology Officer, Parilogix - Biography 

Developing a Medical Information Platform designed to support and enhance our ability to work in a multi-CRO/collaborator outsourced environment. This presentation will take a deep dive into the technologies selected and how we avoid data duplication through standardization and federation to support a diverse community from Clinical Operations to Translational Medicine.

Pharmica Consulting2:20 Leveraging SharePoint for Presenting Clinical Trial Operations Data

Greg CoheeGreg Cohee, Director, eClinical, PHARMICA Consulting - Biography 

PHARMICA Consulting helps pharmaceutical organizations make better decisions with better data. This presentation will showcase an example of how SharePoint can be used to collect, manage, and present consistent data in useful views to different functions.

Sample Minded2:35 Minding the “How” and “Why”; Collection and Annotation of Clinical Research Specimens Based on Study Design and Operational Workflows

Debi KoltenukDebi Koltenuk, Vice President, Products & Services, sampleminded - Biography 

Sampleminded®, an adaptable data management and oversight tool, serves as a conduit between clinical research operations and data warehousing by integrating study design, subject data, assay results, and observational data across sites.  The result is a web-based tool to allow researchers to attain high quality clinically annotated biospecimens for clinical and translational research.

Langland3:00 Refreshment Break in the Exhibit Hall

3:40 User Experience Matters

Anna Kravets, Director, User Experience Strategy, Merck - Biography 

4:05 Leveraging Open Source Technology to Support Data Sharing and Operational Workflows in one Clinical Trials Research PortalBarbara Nagaraj, MPH, Director of the Mechanistic Operations Group for the Immune Tolerance Network (ITN), NIAID
Tanya Antonille, MPH, Associate Director of the Data Management Group for the Immune Tolerance Network (ITN), NIAID
The Immune Tolerance Network (ITN) has recently developed ITN TrialShare, a clinical trials research web portal which provides staff and collaborators access to clinical, research assay and specimen data along with tools for data visualization, collaboration, and operational workflows such as specimen request tracking. In addition, the web portal will soon be made available to the general public; after which anyone will be able to self-register and have read access to ITN closed and published studies.
ITN has chosen to share data in this way because the organization is committed to transparency and data sharing as a means to promoting reproducible research and enhancing scientific collaboration.  We chose an open source development platform so others may benefit from free access and redistribution of the code base.  We believe that open source development promotes wider adoption, allowing different groups to enhance the system based on their specific needs, while mutually benefitting from development work in areas of more universal value.
The ITN Mechanistic Operations group and the ITN Data Management Group have been working together to develop the ITN TrialShare operational workflow and application interface, and would like to share our experiences with the development process and first few months of production use.

4:30 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 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:  How to Use SharePoint in Clinical Trials:
Moderator:  Greg Cohee, Director, eClinical, PHARMICA Consulting
• CRO Oversight
• Document Management
• Project Management Tools
• Data Integration/Reporting
• Workflow

TABLE: Investigator Portals
Moderator: Michael Haushalter, Head, CTMS, Boehringer Ingelheim
• The added value for the Investigational site – What is the functions they need and benefit from?
• What is the impact on the internal organization – Which job functions and processes need to change?
• The sponsor business case – What savings/quantified efficiencies can be expected from an investigator portal?

TABLE: Clinical Data Warehouses
Moderator: Ted Snyder, Senior Analyst, Informatics, Infinity Pharmaceuticals
• 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: Novel Web-Based Technologies and Data Management in Clinical Trials
Moderator: Heather Wolff, Director, Data Management, Infinity Pharmaceuticals, Inc.
• How are sponsors leveraging technology to oversee CROs?
• Is the gap between front and backend applications being closed?  How?
• Given potential changes in site monitoring (e.g. risk-based monitoring, remote monitoring) and sourcing models, what do you see as the challenges for data management in the near future?



Langland5:30 Networking Reception in the Exhibit Hall 

6:30 End of Day

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