Lexology February 17, 2023
The Clinical Trials Regulation (‘CTR’), which came into force last year, has modified (and in some cases increased) responsibilities for sponsors, streamlined reporting processes and improved protection for clinical trial subjects. In light of the regulatory changes, now is a good time to consider best practices when negotiating and performing Clinical Trial Agreements (‘CTAs’).
The following are key contractual issues to consider in order to minimise the risk of subsequent disputes.
- Clarity of obligations: Many disputes in respect of CTAs arise from a lack of clarity in respect of each party’s responsibilities under the terms of the CTA. CTAs should therefore clearly set out the obligations of each party. Parties should define deliverables and deadlines for important milestones, and...
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