cardiabase - one steap ahead in cardiac safety

A FULL RANGE OF
TRIAL EVENT SERVICES

Trial Event Services
  • Event tracking, through creation of a study-specific event database
     
  • Dynamic event reporting at any time required by the sponsor for any particular purpose as data monitoring committee meeting, critical event committee review, safety committee review, steering committee advice support, clinical endpoint committee...
     
  • Collection of source documents
     
  • Blinding of source documents regarding participant identity even for imaging data
     
  • Outcome event adjudication by experts
     
  • Archiving of source documents
Blinding: Beside the treatment blinding for study purposes (single/double blind studies), it is expected as per GCP that any document issued from a patient involved cannot allows sponsor representative, expert or any people to rely to the given subject. Therefore it is mandatory that any document issued from the patient file and used for expert review purpose be blinded about any identifier except the study references.
Adjudication Workflow
 
cardiabase as a CRO provides decision support solutions to the Central Management of Clinical Dossiers Services community. Our solutions improve information sharing among experts and medical organizations, resulting in better care for patients.
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