Following are recent articles providing perspective from Kendle subject matter experts on various clinical development topics, therapeutic areas or current industry trends. New material is added frequently, so check back again soon to view the latest updates.
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Targeted Therapeutics
European Pharmaceutical Contractor, Winter 2005
John Whittaker, PhD, Oncology Therapeutic Director |
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A Practical Guide: Statistics and the Role of the Statistician in Clinical Trial Research
Pharmaceutical Physician, November 2005
Ramesh Amatya, PhD, Associate Director, Biostatistics |
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Candace Kendle --- A candid visionary.
PharmaVoice, November 2005 |
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Focus on Patient Recruitment
Scrip, Fall 2005
Janet Jones, PhD, Global Feasibility Director |
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Winning CROs Look East for Expansion
Pharmafocus, October 2005 (part1, part2) |
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Drug Research Provides Smiles
Cincinnati Enquirer, October 1st, 2005
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Tracking CRO Growth
pharmafocusAsia, September 2005
Alan Davies, MD, MRCP, European Medical Director
Janet Jones, PhD, Global Feasibility Director
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The CRA: A Key to Site Effectiveness
PharmaVoice, September 2005
Christopher C. Bergen, President and COO, Kendle
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ECG Goes Digital
PharmaVoice, September 2005
Melanie Bruno, VP, Global Regulatory Affairs and Quality |
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Chapter 9: Study Design
Clinical Research Manual, September 2005
Alan Davies, MD, MRCP, European Medical Director
John Whittaker, Oncology Therapeutic Director and UK Country Manager |
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Providing CRO Access to Sponsor Data Management Systems
European Pharmaceutical Contractor, Summer 2005
Adam Baumgart, Assistant Director, Biometrics Support Europe
Gill Lawrence, Assistant Director, Clinical Data Management |
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Communicable Risk
Pharmaceutical Marketing Europe,
Summer 2005
Melanie A Bruno, PhD, MBA, Vice President Regulatory Affairs
Ken Hintze, Senior Director, Global Safety & Pharmacovigilance
Martina Gerl, Assistant Director, Safety |
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PAT & the CMC Section of a FDA Drug Regulatory Application
Regulatory Affairs Focus, June 2005
Anthony Celeste, Vice President, Regulatory Affairs
David Barr, Vice President, Regulatory Compliance Consulting, Regulatory Affairs
John Markus, Senior Regulatory Consultant, Regulatory Affairs
Gerald Vince, Senior Regulatory Consultant, Regulatory Affairs |
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An Introduction to the EU Variations System
Industrial Pharmacy, June 2005
Alex Yates, Senior Regulatory Consultant, Regulatory Affairs |
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Post-Marketing Surveillance: Better Late than Never
Pharmaceutical Commerce, May/June 2005
Cynthia Verst-Brasch, PharmD, Vice President, Late Phase
Melanie Bruno, PhD, MBA, Vice President, Regulatory Affairs |
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Diabetes
PharmaVoice, May 2005
Jean Siebenaler, MD, Global Medical Director, Late Phase |
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Proof-of-Concept Trials: From Serendipity to Science
Good Clinical Practice Journal, May 2005
William Sietsema, PhD, Vice President, Clinical Regulatory Strategic Planning, Kendle |
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Pediatric Regulations in Europe & the US
Regulatory Affairs Focus, May 2005
Alan Davies, MD, MRCP, European Medical Director
Michael Bateman, MTOPRA, MRSC, Assistant Director, European Regulatory Affairs
Alex Yates, MTOPRA, CBiol MlBiol, Regulatory Consultant
Melanie A. Bruno, PhD, MBA, Vice President, Regulatory Affairs |
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New Challenges Ahead in
Oncology Drug Development
R&D HANDBOOK, April 2005
John Whittaker, Oncology
Therapeutic Director |
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Kendle - A Very Special K
PharmaTimes, March 2005 |
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Kendle International: Delivering Patient Access Solutions in Established and Emerging Regions
International Pharmaceutical Review, February 2005 |
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Outsourcing in India
India: A Dominant Player
Explaining the emergence of the subcontinent
Contract Pharma, January/February 2005
C. Russ Rutledge, Senior Consultant, AAC Consulting Group, Inc., a subsidiary of Kendle |
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Go East! Clinical Trials in CEE
European Pharmaceutical Executive, January/February 2005 |
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Female Sexual Dysfunction: From Taboo to Treatment
Good Clinical Practice Journal, January 2005
William Sietsema, PhD, Vice President, Clinical Regulatory Strategic Planning
Melanie Bruno, PhD, MBA, Vice President, Regulatory Affairs
Martha Feller, PhD, Senior Vice President, Americas |
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CNS - A Complex Therapeutic and Patient-Recruitment Market
PharmaVOICE, January 2005
Deborah Kniuksta, Assistant Director, Patient Recruitment
William Sietsema, PhD, Vice President, Clinical Regulatory Strategic Planning |
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