Venn Life Sciences offers legal services to support clients in study related regulatory and contractual obligations.
Investigator, site and other vendors’ contract negotiation and management
We draft, negotiate and conclude Investigator, site and other provider agreements (e.g. pharmacy, lab, etc.), based on our extensive experience. Contracts are tailored to each country’s legal requirements, business culture and activities. We constantly seek to streamline the processes in order to shorten the timelines to allow for the efficient start-up of activities.
We further manage these contracts throughout the lifecycle of the study, for example where amendments or extensions are required.
The European Clinical Trials Directive (2001/20/EC) and Directive 2001/83/EC concerning medicinal products for human use require that for all clinical trials carried out in the EU, a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area.
We offer full legal representation to sponsors not established within the EU and Switzerland, as required under these EU Directives.