Articles and White Papers by Aptiv Solutions Experts
2012 Articles/White Papers
October 2012
“Understanding the Regulatory Drivers for Adaptive Design Trials”
Dr. Phillip Birch, Senior Vice President, Aptiv Solutions
As seen in the Oct 2012 Issue of Regulatory Rapporteur Magazine, Pages 16-17
September 2012
“Design and Execution of Early Phase Adaptive Trials: Maximising R&D Efficiency and Productivity”
by Dr. Vlad Dragalin, SVP of Clinical Trial Innovation Strategies; Sarah-Arbe Barnes, SVP, Translational Sciences; and Moira Thomson, VP, Translational Sciences
July 2012
”Innovative Trial Design: The Road to Commercial Success”
As seen in the Summer Issue of World Pharma’s Clinical Trials Insight Magazine
Read Article in Clinical Trials Insight Magazine, Page 48
April 2012
“Population Enrichement Designs for Adaptive Clinical Trials”
by Reinhard Eisebitt, Executive Vice President and Head, Innovation Center, Dr. Vlad Dragalin, Senior Vice President of Clinical Trial Innovation Strategies and Gernot Wassmer, Senior Vice President, Software Architecture
March 2012
“Implementation of Adaptive Clinical Trials”
-by Corey Dunham, SVP, Global Data Management; Martin Geueke, SVP Software Design and Judith Quinlan, SVP, Trial Design Implementation
“Adaptive Trial Designs- Evolution or Revolution” by Judith Quinlan, SVP, Trial Design Implementation
- As seen in European Pharmaceutical Contractor (EPC), March 2012
February 2012
“US FDA Medical Device User Fee Update” by Rosina Robinson, Affiliate Principal Regulatory Consultant
-As seen in the Journal of Medical Device Regulation, February 2012
2011 Articles/White Papers
May 2011
“The Growth of Adaptive Designs” by Judith Quinlan, SVP Adaptive Trial Design Implementation
-As seen in Contract Pharma magazine
July 2011
“Adaptive Clinical Trials – What’s it All About?” by Birant Osman, Director of Business Development
-As seen in the PCMG Newsletter
September 2011
“The Impact of an Integrated Execution Environment on Data Management in Adaptive Clinical Trials” by Corey Dunham, VP Data Management & Statistics
-As seen in PharmaVoice magazine
November 2011
“Adaptive Trial Designs- Looking for Answers”
by Andy Grieve, Senior Vice President, Clinical Research Methodology
-As seen in International Clinical Trials magazine
“Paradigm Shift on the 510(k) Process? More like a nine on the Richter scale with ‘fallout’ likely to follow”
by Rosina Robinson, Affiliate Principal Regulatory Consultant
-As seen in the Journal of Medical Device Regulation
