Chiltern becomes the first international organisation to be awarded both a CRO and sponsor password for the new clinical trials database system in Italy
Clinical research organisation Chiltern International has become the first international organisation to be awarded both a CRO and sponsor password for the new clinical trials database system in Italy.
The new system is being developed in the run-up to the implementation of the EU Clinical Trials Directive.
One of the key features of this will be the establishment of the Eudract database that will allow European regulatory authorities to have an overview of clinical trials being conducted in the community. The database will represent a register of all clinical trials in the European Community, containing information on the content, commencement and termination of the clinical trials and on inspections.
Although full compliance with the EU Clinical Trials Directive is a year away, various EU member states are already preparing for its implementation.
Italy has already set up a clinical trials database in anticipation of Eudract and from now on all clinical trial information will need to be entered into the database.
In order to do so, a company-specific password for the database is required.
In Italy, all sponsors must have approval to use the database system before they can carry out submissions to the competent authorities or ethics committees. Chiltern is the first international organisation to achieve this approval.
The involvement of Chiltern's Italian based staff member, Mauro Germinario, was crucial to the process.
"This is an exciting time for the development of European clinical trials," commented Patricia Lovell-Hoare, Chiltern's head of international regulatory affairs.
"We are delighted to be the first international CRO to be awarded passwords for the Italian system.
"It is a reflection of our continuing commitment to offer clients the very latest options in regulatory services."
