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eClinical Integration Brochure

2011 Agenda

Monday September 19, 2011 • Pre-Conference Workshop Day
Pre-conference workshops are designed to maximize time for delving into topics at the core of your learning and skill set needs. Sessions are meant to be interactive so come prepared to join the discussion! Workshops are an excellent opportunity to exchange ideas and network in an intimate setting.
7:30am Registration Opens
1:30pm Afternoon Workshop Begins
2:30pm Networking Break
3:00pm Workshop Resumes
4:45pm Cocktail Reception
hand icon Afternoon Workshop: Part 1
e-Solutions Planning for Startup and the Conduct of Clinical Trials
Jon Taie, CCDM, CCRP, Clinical Data Manager, Harvard Clinical Research Institute
Eloisa Rodriguez, Senior Manager, Clinical Data Management, Allergan
Topics:
  • Review of e-Technology – what to use? EDC fundamentals
  • Overview of e-Technology Milestones and Project planning
  • Key stakeholders, who are they?
  • Validation and Acceptance Testing, what’s involved
  • Training Approach for Users
  • Documentation and Administration
  • Selecting and working with a vendor Partner
phone icon Afternoon Workshop: Part 2
Mobile Devices and eClinical Data Communication
Jeff Lee, CEO, Omniscience Mobile
When it comes to successfully completing clinical studies, keeping patients enrolled is vital. Lengthy trials pose a significant risk of patients dropping out, especially where invasive procedures are involved. In studies that include add-on trials, every patient's continued participation grows even more valuable while making sure patients stay on course with all study requirements adds to this burden. Effective retention and compliance continues to be the most critical need however, what is effective retention if it is not targeted? This is where mobile technologies can play a critical role. In this workshop, attendees will gain understanding in:
  • Use of Mobile Devices for Clinical Trial Recruitment
  • How innovations in tablets and smartphone development affect ePRO and IVRS systems
  • The use of mobile at the clinical site for efficient and streamlined data capture
  • Features, benefits and costs of implementation
Tuesday September 20, 2011 • Main Conference Day 1
7:45am Registration & Morning Coffee
8:30am Chairperson Welcome Opening
Darlene Kalinowski, Associate Director, eDC Operations, Bristol Meyers Squibb
star icon INDUSTRY UPDATE, REGULATIONS & STANDARDS
8:45am KEYNOTE: Charting a Course for New Models of Innovation
Ken Getz, MBA, Senior Research Fellow and Assistant Professor, Tufts CSDD, Founder and Chairman, CISCRP
9:30am Future Trends: Patient-Centered Clinical Trials:
Innovative Technology Integration Enabling Clinical Trial Participation from Home
Craig Lipset, Director Global Clinical Technology, Pfizer
Click Here to download Craig's pre-event podcast
10:15am Networking Break in Clinical Business EXPO Exhibit Hall
11:00am Getting Results with CDISC and Standardization
Julia Zhang, Associate Dir / Standard Program Manager, Genzyme
11:45am FDA Perspective and Panel Discussion Surrounding eSource Guidance
Jules Michael, CEO, Target Health
Darlene Kalinowski, Senior Manager Regional Clinical Ops, Bristol Myers Squibb
12:30pm Strolling Lunch in Clinical Business EXPO Exhibit Hall
star icon IMPLEMENTATION
1:45pm KEYNOTE: Accelerating Opportunities for Innovation in Human Health
Ray Kurzweil, Expert on Innovation, Singularity University
2:30pm Site Perspective: Site Weigh in on Electronic Data Management and InterOrganizational Communication
Adam Larabee, Director of Business Development, Rochester Clinical Research
3:15pm Networking Break in Clinical Business EXPO Exhibit Hall
4:00pm Innovations in Data Warehousing
Rajesh Subramanian, Sr. Manager Clinical Programming, Allergan
5:15pm
Golden cup icon
eClinical Integration Summit Awards
5:30pm Networking Reception inClinical Business EXPO Exhibit Hall.
Wednesday September 21, 2011 • Main Conference Day 2
7:30am Morning Coffee in Clinical Business EXPO Exhibit Hall
INTEGRATION
9:00am Integration of EHR data to benefit Patient Screening and Optimize Quality of Trials.
David Leventhal, Director of Healthcare Informatics, Pfizer
9:45am Integration, Not Reconciliation: Boehringer Ingelheim's Plan to Integrate SAE
collection with EDC

Susana Domingos, Associate Director in Drug Surveillance and Information, Boehringer Ingelheim
Tricia Gregory, Sr. AD Global BDM, Boehringer Ingelheim
10:15am Networking Break in Clinical Business EXPOExhibit Hall
11:00am eGlobalization Issues with Integration: The Challenge of Language When it
Comes to Data

Karen Virk, Director of Biopharmaceutical Research, Language Connections
11:45am A Picture is Worth a Thousand Tables: Cutting Edge Visualization Output
of Data Outcomes

Steve Sweeney, Head of Clinical Operations, Infinity Pharmaceuticals
12:30pm Conference Concludes
Clinical Business EXPO

This event is part of the Clinical Business Expo, a unique opportunity to network across the clinical development continuum with over 200 leading expert speakers, 600 + executive attendees and 50 exhibitors. For more information,visit www.ClinicalbusinessExpo.com.

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