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Strategies for Implementing CDISC
Thomas Kalfas
December 2011
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Streamlining Data Management Start-up
Cheryl Silva
November 2011
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IVR/IWR...More than just Randomization
Ryan Michaud and Bruce Bailey
October 2011
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The Role of Data Monitoring Committees
Ronald Kershner, Ph.D.
September 2011
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Pediatric Considerations beyond Assent
Charlene Sanders, M.D. and Angi Robinson
May 2011
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Guidelines for Effective and Appropriate
Pediatric Assent and Parental Permission
Angi Robinson and Elizabeth Jay, RN, MA
April 2011
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Planning your Paediatric Investigation Plan (PIP)
Submission in Europe
Susan Bhatti, Ph.D.
March 2011
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Developing a Feasible Pediatric Plan for PREA/PMDSIA Compliance
Charlene Sanders, M.D.
February 2011
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Optimizing Country Selection in Oncology Clinical Trials
October 2010
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Lessons Learned from Pharmacovigilance Audits
Hal Ward, R.Ph., Pharm.D.
June 2010
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Using Functional Sourcing Effectively: A Review of Successful Projects
Ajay Sadhwani
April 2010
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