EU CLINICAL TRIAL DATABASE NEEDS BACK-UP SYSTEM SAYS PHARMA INDUSTRY

  THE EUROPEAN Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has called for the creation of a backup system to the European Union’s (EU) clinical trial database and portal, in case of technical failures. In formal public consultation comments on the operation of the harmonised clinical trial data reporting system created under the EU’s 2014 clinical trial regulation (536/2014), EUCOPE asked: “…in case the portal breaks down…would it be perhaps be possible to submit via Eudralink in such an instance?” The confederation also asked if for ...


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