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Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials

 
• By Francesca Bruce

Industry is wary of a provision in Germany’s medical research bill that would introduce standard clauses in the contracts agreed between trial sponsors and study sites.

negotiation
New bill in Germany seeks to simplify negotiations for agreements between clinical trial sites and sponsors • Source: Shutterstock

In a bid to make Germany a more desirable clinical research location, a new bill has been drawn up that would harmonize rules governing advanced therapies and introduce measures to facilitate decentralized clinical trials (DCTs).

These measures have been welcomed by industry, but another that would introduce standard contractual clauses for agreements between clinical trial sponsors and sites is being treated with more caution, said...

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