Our services include:

• Provision of qualified PV personnel (including QPPV, QPPV deputy, local PV contact, and medically qualified staff)
• Establishment and maintenance of PV systems
• Development and maintenance of Pharmacovigilance System Master Files (PSMF)
• Development and maintenance of Standard Operating Procedures (SOPs)
• Global and local literature monitoring
• Management of Individual Case Safety Reports (ICSRs)
• Generation and submission of aggregate safety reports
• Development and maintenance of Risk Management Plans (RMPs)
• Signal management
• Management of Direct Healthcare Professional Communications (DHPCs)
• Management of Risk Minimization Measures (RMMs)
• Monitoring of regulatory intelligence
• Electronic reporting of Individual Case Safety Reports (ICSRs)
• XEVMPD data management
• Audit and inspection readiness
• Pharmacovigilance training for both PV and non-PV personnel
• Management of pharmacovigilance agreements

We also offer pharmacovigilance support for veterinary medicinal products.

Clinres Farmacija offers complete drug safety development services during clinical trials including:

• Service of experienced professionals (responsible person for pharmacovigilance, and back-up),
• Registration with Eudravigilance Clinical Trial Module,
• Establishment of Standard Operating Procedures (SOPs) on clinical trial pharmacovigilance and other controlled quality documents,
• Management of cases and case processing (SAE),
• SAE medical review, MedDRA coding,
• Safety data reconciliation,
• Preparation and submission of Development Safety Update Reports,
• Preparation and submission of periodic SUSAR reports,
• Electronic reporting of Suspected Unexpected Serious Adverse Events (SUSARS),
• Reporting to Regulatory Authorities and Ethics Committees as appropriate,
• Supporting assessment of risk-benefit ratios throughout the trial and updating the Investigator Brochure as necessary,
• Developing of risk management plans in full compliance with regulations.

 
We offer dedicated phone and fax lines which enable you to personally contact a safety officer.