Prepping your Clinical Data for a Successful Exit!

Tuesday, December 4 2012

Location: Cambridge Boston Marriott

BOSTON CAMBRIDGE MARRIOTT
Two Cambridge Center
50 Broadway
Cambridge, Massachusetts 02142

Due Diligence activities are now more than ever becoming a mission critical activity for those looking to in-license or out-license their compounds and biologics. In particular, companies should not overlook the quality and integrity of the study data, both clinical and nonclinical.  Standards have been developed and are being applied to this data that must become part of an overall due diligence exercise. With the release of the draft guidance it is imperative to understand the importance of having data standardized.  This seminar will break down due diligence activities from a clinical and regulatory perspective. 

  Topics to be discussed:

  • Background of Due Diligence Process
  • Data Management Due Diligence Activities -acquisition through standardizing of their data
  • Bio Statistics Due Diligence Activities with a focus on safety and efficacy
  • Importance of Standards at Regulatory Stage
  • Blinded Case Study

Presenters:

Jeff Davidson - Sr. Director, Biostatistics, Clinical Statistics, Octagon
David Izard - Director, Data Integration and Standardization, Octagon
Nancy Smerkanich - Vice President, Regulatory Affairs, Octagon 

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