Electronic exchange of individual case safety reports (ICSR) according to ICH E2B has become a global standard, which is obligatory in Europe and Japan.
Once implemented it saves resources and time in the daily exchange of case reports.
However, the investment is huge and the selection of the best fit out of a variety of possible technical systems is challenging.
spm² would support the identification of a suitable and cost efficient safety database as well as the in-house implementation.
Alternatively we could offer to maintain and run the entire system via an out sourced solution.
Regardless whether you choose an external or internal safety database, our IT experts would help you to define your user requests and workflows and manage installation and validation of the system.