Our Legal department team is highly experienced in negotiation of clinical trail agreements on international level , EU and national requirements and in multilanguage environment.
We provide detailed advisory 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)
The European regulatory framework for trials and affects on a terms of agreements.
CTA development
Budget development
Other laws and regulations affecting CTAs, including data protection, freedom of information, “sunshine” laws, and many other topics.
Other agreements and documents used in clinical trials.
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