Strategic Clinical Development Planning: Designing Programs for Winning Products

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March 2005

Here’s an essential guide for drugmakers looking to streamline the trials process for faster FDA approvals and major cost savings. You’ll find loads of expert advice plus case studies — actual experiences of manufacturers like you who brought products to market successfully once they learned the right way to plan and manage clinical trials.

The book helps readers —
  • Discover how to cut waste
  • Identify which trials are “must do” and which can be delayed
  • Choose the most powerful clinical endpoints to optimize product usage
  • Register products worldwide
  • Manage patient safety
  • And much more

“This is a ‘must read’ book for those who want to gain a solid foundation on the basics of strategies involved in clinical trial design and clinical development”, according to Kevin L. Skare, Ph.D, Adjunct Professor of Pharmaceutical Sciences for the University of Cincinnati’s College of Pharmacy, and Senior Director of Global Clinical Operations for Procter & Gamble Pharmaceuticals.

Click here for more endorsements of this book by industry professionals.

Meet the Author
William K. Sietsema, Ph.D. is vice president of clinical and regulatory strategic planning for Kendle International Inc., a global CRO delivering innovative and robust clinical development solutions to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. His 21-year career includes positions as a scientist, drug developer, bone researcher and director of clinical research for Kendle and Procter & Gamble. A Phi Beta Kappa graduate of the University of Colorado, he is also adjunct professor of pharmaceutical sciences at the University of Cincinnati’s College of Pharmacy where he teaches drug development principles to medical students, pharmacists and industry representatives.

Strategic Clinical Development Planning is one of several FDAnews publications dedicated to getting your product on the market — and keeping it there. Get more information on other books covering drug approval:

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