| 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 |
| 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:
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| 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:
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| 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 |
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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 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 Exhibit Hall |
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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 Exhibit Hall |
| 4:00pm | Innovations in Data Warehousing Rajesh Subramanian, Sr. Manager Clinical Programming, Allergan |
| 5:15pm |
eClinical Integration Summit Awards |
| 5:30pm | Networking Reception in Exhibit Hall. |
| Wednesday September 21, 2011 • Main Conference Day 2 | |
| 7:30am | Morning Coffee in 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 Exhibit 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 |
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.











Exhibit Hall