Tuesday, October 26, 2010 — Optional Pre-conference Workshops
  1:00-4:00pm Streamline Study Development Using Central Designer™

Advanced Topics in Signal Detection
  7:00-8:30pm Welcome Reception
Wednesday, October 27, 2010 — IUC Day One
  8:00-8:45am Registration and Breakfast
  9:00-12:00pm Welcome and Opening Remarks

Industry Keynote

Solutions Update

  12:00-1:15pm Lunch
 
eClinical Track A:
eClinical Track B:
 Safety Track C:
  1:15-2:15pm
Product and Solutions Update - Clinical Product and Solution Update – Safety
  2:15-5:00pm
Topics
  • Best practice case studies of Central Designer, Central Coding, InForm GTM, Phase Forward IRT, and the InForm GTM/Phase Forward IRT combined solution
  • Converting clinical data into SDTM format
  • Leveraging standards and libraries
  • Best practices for maintaining subject participation and compliance in late phase clinical research
  • Dynamics of EDC in specific therapeutic areas
  • Moving to Web-based ePRO
  • Migrating data to central repositories
  • Strategies for streamlining data preparation for analysis
  • Meeting the needs of increased post-marketing surveillance
 Topics
  • Emerging trends in pharmacovigilance
  • Best practice case studies of Empirica Trace, Empirica Signal and Empirica Study
  • Signal detection and managing signals
  • Opportunities for using healthcare data to improve drug safety
  • Identifying drug interactions using logistics regression
  7:00pm Cocktails  
  7:30pm Networking Dinner and Entertainment  
Thursday, October 28, 2010 — IUC Day Two
  8:00-8:45am Breakfast
  9:00-11:00am Welcome

Customer Keynote

 
 
eClinical Track A:
eClinical Track B:
 Safety Track C:
  11:00-12:30pm
Topics
  • Improving operational efficiencies
  • Managing increased protocol complexities
  • Capturing and managing data from all sources
 Topics
  • Impact of data standards on pharmacovigilance
  • Improving safety signal detection in clinical trials data
  12:30-1:30pm Lunch  
 
eClinical Track A:
eClinical Track B:
 Safety Track C:
  1:30-5:00pm
Topics
  • Approaches for optimizing analysis and reporting while meeting regulatory needs
  • Strategies on migrating to new software versions
  • Using ePRO as part of a risk evaluation and mitigation strategy
  • Automating analysis to get the most out of your clinical data
  • Managing the analysis process to meet submission timelines
 Topics
  • Integrating clinical and safety
  • Updates on evolving regulatory requirements (RMPs and REMS)
  5:00pm Conference Adjourns  
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*Please note: Time slots and track topics are tentative