Our Pharmacovigilance professionals offer:

• Expert advice on PV system requirements
• Providing Qualified PV personnel (a QPPV, QPPV deputy, local PV contact and medically qualified personnel)
• Development, implementation and maintenance of the PV system
• Preparation and maintenance of PSMF
• Preparation and maintenance of Pharmacovigilance SOPs and other controlled quality documents
• Preparation or review of PV agreements or safety data exchange agreements with business partners
• A safety data receipt and processing
• Signal detection and evaluation
• Regular worldwide and local literature screening for case reports and other safety information
• Electronic- or paper-based reporting to EMA and European competent authorities
• Preparation of Periodic Safety Update Reports, Summary Bridging Reports, Addendum Reports, and other Aggregate Safety Reports
• Risk Management Plans
• PV trainings for PV and non-PV personnel
• Creation of XEVPRMs
• PV Audits, preparation of Corrective Action Plan, implementation of CAPA
• Labelling evaluation and variations
• Crisis management

We can also offer our support in PV for veterinary 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.