The Growing Cost of Compliance and the Impact on Clinical Trials
Sponsored by: World Courier
Date: 12 May
Time: 4pm BST / 11am EDT
How Logistics choices can improve cost and patient safety
In a global clinical trial, cost is often a function of process rather than science âˆ’ the more compliant the supply chain, the more cost-effective the study. Consider, for example, that the difference between 99.8% and 97% stability in the delivery of patient specimens to the lab for a typical 5,000-patient Phase III clinical trial (seven visits at $15,000 per patient) is $2.1 million! And that is just the beginning...
Join us on May 12, 2011 for an insightful discussion by Stephen Sullivan, Founder of CRO Advisors LLC, and Dr. RÃ¼diger Lomb, Global Director of Quality and Technical Compliance for World Courier, on making logistics choices to ensure compliance, improve patient safety and reduce unnecessary clinical trial risk and costs, especially in emerging nations.
In his presentation, Mr. Sullivan will discuss the growing issue of compliance in drug development, one of the greatest areas of regulatory risk in emerging countries. He will also explore the role of logistics âˆ’ a critical component in the integrity, safety and cost of these increasingly complex clinical trials âˆ’ and outline supplier selection criteria including ways to assess and improve supply chain performance.
Dr. Lomb will similarly address the complexity of the global clinical supply chain and the challenging distribution environment it presents for researchers who must ship large volumes of temperature-sensitive investigational drugs and patient kits worldwide. He will discuss the importance of GxP compliance throughout the entire cold chain distribution process to protect chain of custody while eliminating unnecessary cost and risk.
Founder, CRO Advisors LLC
Steve Sullivan founded CRO Advisors LLC in early 2010 to help CRO leaders, partners and investors to find strategic solutions in a rapidly changing outsourced drug development industry. Steve was CEO of Harlan Laboratories, a leading pre-clinical and research models and services company for four years. Prior to Harlan, Steve was a Senior Vice President with Covance, Inc., the largest public CRO since 1999. Steve managed Clinical operations for three years and the Central Laboratory Group for four years.
Dr RÃ¼diger Lomb,
Global Director, Quality & Technical Compliance
Dr. RÃ¼diger Lomb is Global Director, Quality & Technical Compliance for the World Courier group of companies. Since joining World Courier in 2008, Dr. Lomb has brought his considerable technical expertise to bear on shaping and refining the company’s Quality Assurance program. Dr. Lomb was formerly Group Head and Director of the Global Logistics Clinical Supplies Division for Bayer Schering Pharma AG in Germany where he was responsible for the auditing and qualification of depot and transportation service providers. Dr. Lomb is a licensed pharmacist and holds a Ph.D. in pharmaceutical bio-chemistry.
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Key Learning Objectives
- Growth of clinical trials in emerging countries
- The rapidly evolving regulatory environment
- Increased complexity of clinical trials
- How logistics choices can improve safety and cost
- Novartis Vaccines & Diagnostics - Head of Business Operations (Serology)
- ICON Clinical Research - Logistics Manager
- Roche - Biosample Operations Manager
- Pfizer - Clinical Research Drug Supply and Import Associate
- Astellas Farma - Clinical Research (Associate Director)