Interfaces between CTMS, EDC, and Drug Safety
Hauke Kindler - Reliable Lifesciences Consulting (RELICO)

The information flows between CTMS, EDC, and Pharmacovigilance will be identified. For instance a clinical trial will show up in all systems.

Common problems of synchronisation will be discussed, e.g. if the length of the trial name in the CTMS may be longer than in the EDC system trials cannot be named the same way in both systems which makes interfacing  difficult. The mitigation of these problems will be discussed.

It has become industry standard over the last years to use computerised system for trial management, clinical data caputre, and pharmacovigilance. Different ways of realising interfaces between the systems will be demonstrated and presented in the light of benefit versus cost, e.g. a manual interface may be cost efficent for 4 trials per year, in contrast a computerised interface may allow cost savings for high amounts of information to be exchanged despite being expensive.



 

 
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