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Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy
Session Chair(s)
Pamela Lindroos, PhD
Senior Director, Medical Writing
WebbWrites, LLC, United States
This forum will discuss how the preparation of high-quality clinical study reports (CSRs) and summary documents for a New Drug Application (NDA) may be achieved by preparation of shell documents, adherence to guidance documents, avoidance of redundancy within and across documents, and structured authoring.
Learning Objective : Describe approaches that help the medical writer decrease the time to preparing documents; Discuss pros and cons of preparing shell documents; Discuss characteristics of lean documents that avoid both redundancy and inconsistency across submission documents; Identify the potential of structured authoring to drive efficiencies in document production.
Speaker(s)
Writing Clinical Documents for Regulatory Submissions
Pamela Lindroos, PhD
WebbWrites, LLC, United States
Senior Director, Medical Writing
Structured Authoring: Driving Improved Efficiency, Quality and Costs
Kristina Brannstrom, PhD
Quintiles Inc., United States
Director and Regional Head, Global Medical Writing and Document Publishing
Medical Review of Clinical Documents for Regulatory Submissions
Helen Colquhoun, MD, FFPM
CROMSOURCE, United States
Senior Vice President
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