Key Takeaways
- Germany will soon introduce standardized contractual clauses for clinical trial agreements to speed up negotiations between sponsors and study sites.
- Sites may view the standardized clauses as having been introduced by a neutral “third-party” and may be reluctant to deviate from them, making negotiations more difficult.
- To benefit fully from the standardized clauses when they are introduced, sponsors
- Where changes may be needed, companies must have compelling arguments for why some of the clauses are not acceptable.
Forthcoming standardized contractual clauses to be used in clinical trial agreements will speed up the negotiation process between sponsors and trial sites in Germany, say legal experts. However, sites will...
The Medical Research Act, published in 2024 as part of a wider strategy to boost clinical research and drug production in Germany, set out plans for standardized contractual clauses for...
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