Adaptive Research: Clinical Trials Renaissance
(recorded on June 3, 2010)
 

Sponsored by: MaxisIT, Inc. 

Purchase DVD or Electronic Version 

Program Description:

 

The Draft Guidance for Adaptive Clinical Trials, published by the FDA, addresses the apprehension in the pharmaceutical industry by simplifying regulatory issues and setting realistic expectations, as well as outlining standards and requirements that can be attained through a suitable infrastructure.  Adaptive Clinical Trials offers huge benefits because of its inherent strong control of a study, which becomes even more powerful with harmonized processes in an integrated computing (eClinical) environment.  However, this new approach requires a business transformation and an enterprise-wide architectural alignment – an exit from the traditional mindset clinical trials.  People, processes, and computing infrastructure must become truly synergistic in order to reap the benefits offered by Adaptive Clinical Trials, thereby minimizing potential risks or, even worse, biased actions jeopardizing success.  Thus, each decision must be supported by strong evidence indicating Why, What, Who, When, and even How.  A holistic infrastructure requires true harmonization and complete integration, that is, one that can deliver built-in integrity including real-time metrics.  This complimentary web symposium will provide a 360 degree view into the key issues surrounding Adaptive Design and the need for a scalable infrastructure for conducting Adaptive Clinical Trials that imbues a timely decision-making process.

Key Learning Objectives: 

This symposium will provide an insight on:

• Standardization & Integration 
• Dashboards to Monitor, Assess, and Adapt 
• Built-in controls (firewalls) to ensure Integrity 
• Decision-making Process & Structure 

Attendees will gain understanding about the technology needed to address the logistical and clinical issues surrounding Adaptive Design.

Who Should Attend: 

• Executives in Pharma, Biotech, and Academia 
• Biostatisticians, Analysts, Data management professionals, IT professionals, Regulatory professionals, Researchers, Scientists, Physicians, and other professionals involved in adaptive clinical trials planning, execution, management, monitoring, decision making and reporting 

Speakers:

• Frank Newby, COO, CDISC
• Jerald Schindler, Dr.P.H., VP Late Stage Clinical Development Statistics, Merck
• Maulik Shah, VP, CTRenaissance^TM Product Division, MaxisIT, Inc.