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 interactive two day course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight.
This course is also available to study online, check website for dates>>
John Shillingford, PhD, is an independent consultant whose career in both the Pharmaceutical and CRO industries has stretched over 30 years. His wide experience of drug development in Europe and the USA has been acquired during the management of both clinical and data operations for major global programs. A major focus has been to successfully commence and manage operations in the countries of Central and Eastern Europe and integrate these research units into global operations.
All professionals who are involved in vendor oversight will benefit from this course, including:
The trainer has a wealth of knowledge and generously shared it with the participants. This training gave me a lot of ideas how to improve the vendor oversight in my company.
The practical insight on how CROs work in this course was excellent.
Webinar 1: 7 Sep - 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: 19 Sep - A process for managing change
The 8 step approach to change, guides in managing change, example of process in action