Drug safety

Drug safety/pharmaco-
vigilance

Good Clinical practice (GCP) guidelines, EU CTR 536/2014 and country-specific regulations require evaluation and reporting of safety concerns. To support sponsors in this responsibility, Nuvisan can provide: 
 
Principal investigator oversight

• Taking care of participants' well-being during clinical trial conduct
• Recording and evaluation of adverse events (AEs) regarding causal relationship, severity and seriousness
• Provide on-call duty (24/7)
• Input to study protocol and final clinical study report (CSR).

Medical monitoring

Review and evaluation of all safety data, including:

• Preparing the medical monitoring plan (MMP)
• Ensuring timely identification and reporting of all serious adverse events (SAEs) 
• Immediate reporting of all alarming safety incidents to the sponsor
• Participating in Dose Escalation Committee (DEC), if applicable
• Organising and managing independent safety committees (Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC)), where usually the medical monitor and investigator participate in an open session.

Pharmacovigilance

• Designation of a “responsible person” (RP) for pharmacovigilance
• Registering sponsors in the EudraVigilance database
• Product registration in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD / Article 57 database)
• Preparation of a safety management plan (SMP)
• Preparing a trial-related safety database
• Management, processing and reporting of serious adverse events (SAEs)
• Entry of SUSARs / expedited reporting into the EudraVigilance Clinical Trial Module (CTM) in the ICH E2B(R3) format within the 7- and 15-day timeline
• Provision of line listings of SUSARs and updated benefit-risk evaluations
• Act as liaison with authorities for safety reporting
• Reconciliation with the clinical database
• Input to development safety update report (DSUR) for Nuvisan-supported trials.