It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimise the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this essential 10-module course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight over 5 weeks.
• Introduction to the complexities of vendor selection, management and oversight
• Review of different outsourcing strategies and models
• Different outsourcing models from strategy, through vendor selection and effective implementation
• Comprehend your responsibilities as the sponsor both from GCP perspective and from vendor management perspective
• Identify the right level of management and oversight
• Understand the outsourcing strategies for selecting, monitoring and communicating with your service providers
With over 25 years’ experience in clinical development, Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen). Julianne is now CEO of WenStar Enterprises, a company she formed to provide consultancy to the pharmaceutical industry in the areas of clinical outsourcing and operations.
All professionals who are involved in vendor oversight will benefit from this course, including:
PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Webinar 1: The effect of the contract on performance
Common sponsor concerns about partner performance, things that make people perform at their best, practical tips on getting it right
Webinar 2: A process for managing change
The 8 step approach to change, guides in managing change, example of process in action