This course provides a detailed discussion of the legal, regulatory, drafting and practice issues that arise when drafting and negotiation clinical trial agreements (CTAs) and other contractual documentation that is encountered when clinical trials are run, e.g. agreements between a sponsor and a clinical research organisation (CRO). Topics that are discussed include:
- What makes CTAs different from other professional services agreements.
- The European regulatory framework for trials and how this affects the terms of agreements.
- Other laws and regulations affecting CTAs, including data protection, freedom of information, “sunshine” laws, and many other topics.
- Standard agreements – governmental, company, etc: when are they used, when are they not; and how are they revised.
- Drafting and negotiation issues.
- Practical aspects of working with colleagues to get the agreement right.
- Other agreements and documents used in clinical trials.
Who is the course for?
The course is designed for contracts managers, lawyers and project managers who have had some exposure to CTAs but are not experts and do not have years of experience of negotiating them.
Please contact Mark Anderson for more information or to register your interest to attend this course.