Clinical trial agreements are some of the most important agreements for life sciences companies and the pharma industry. Clinical testing of new products cannot start until the sponsor and health care organisation have entered into an agreement, and the legislation and guidance set out details of what these agreements should include. If appropriate arrangements are not in place, a trial may not receive approval, or issues may arise with the integrity or validity of the data collected. Clinical trial agreements are therefore key to managing the relationships, risks and responsibilities of the parties involved, and ensuring that each party's interests are protected.
Key topics covered in this seminar:
- Overview of the legal/policy landscape as it affects the terms of clinical trial agreements
- The typical clauses that make up a clinical trial agreement
- How to recognise and tackle key commercial and regulatory issues that arise
- Drafting and negotiating techniques to minimise disputes and maximise efficiency
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