Eu­rope preps for the launch of its new clin­i­cal tri­als data­base, with a push to in­crease tri­al par­tic­i­pa­tion

At the end of this month, the Eu­ro­pean Med­i­cines Agency will roll out its new, long-await­ed Clin­i­cal Tri­als In­for­ma­tion Sys­tem, a one-stop-shop for all clin­i­cal tri­al doc­u­men­ta­tion in the EU that will al­so sup­port the spon­sors and reg­u­la­tors through­out the tri­als.

Once it’s live, CTIS will of­fer a sin­gle clin­i­cal tri­al ap­pli­ca­tion dossier, cov­er­ing clin­i­cal tri­al ap­pli­ca­tions sub­mit­ted to EU/EEA mem­ber states (and to Na­tion­al Com­pe­tent Au­thor­i­ties and ethics com­mit­tees) and reg­is­tra­tion of the tri­al, all in one in­te­grat­ed sub­mis­sion.

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