Site Selection

Prior to the initiation of the clinical trial, the qualifications of the principal investigator and adequacy of the site must be verified and documented in an investigation site selection report. Sounds complicated? No worries, FE.BE Consulting is a part in the selection of the right site for trials.

Study Approval

Obtaining an approval for your study could be tricky if you get lost in submitting relevant study documents to competent authorities and ethic committees. FE. BE Consulting will follow every step for you from start-up study to completion.

Site Initiation

Our specialized team can define the activities required for the initiation of investigation sites in accordance with EN ISO 14155 and GCP/ICH. Our monitoring plan seeks to check and document regulatory approval, to complete site opening procedures and prepare for enrollment of the first patient.

Risk-based Monitoring

There is no clinical trial without risks.  FE:BE Consulting team will assess and define a risk plan associated with medical devices subjected to clinical investigations, in order to proactively react to those risks and mitigate the effects.