Drug safety

Drug safety/pharmacovigilance

GCP guidelines and country-specific regulations require evaluation and reporting of safety concerns. To support sponsors in this responsibility, Nuvisan can provide: 
 
Principal investigator oversight 
1. Taking care of participant well-being during clinical trial conduct.
2. Recording and evaluation of adverse events (AEs) regarding causal relationship, severity and seriousness.
3. Provide on-call duty (24/7).
4. Input to study protocol and final clinical study report (CSR).
 
Medical monitoring activities such as review and evaluation of all safety data, including: Dose Escalation Committee (DEC), Data Safety Monitoring Board (DSMB) and Independent Data Monitoring Committee (IDMC) reviews.
 
Pharmacovigilance 
1. Preparation of a safety management plan (SMP).
2. Management, processing and reporting of serious adverse events (SAEs).
3. Input to development safety update report (DSUR) for trials in which Nuvisan is involved.
4. Act as liaison with authorities for safety reporting.
5. Qualified person for pharmacovigilance (QPPV) services.
6. Preparing a trial-related safety database.
7. Registering sponsors and entry of SAEs into the EudraVigilance database  
8. If applicable, communication of suspected unexpected serious adverse reaction (SUSARs), SAEs and adverse events of special interest (AESIs) to the health authorities, ethics committees and other appropriate institutions.
9. Reconciliation with the clinical database.
10. Expedited reporting.