August Research’s Pharmacovigilance Services are focused on providing high-quality, customized solutions for clinical trial sponsors and CROs, from our PV center in Sofia, Bulgaria.
Our services include:
Safety Management Strategies – Developing project specific Safety Management Plans (SMPs) for drugs, biologics and vaccines and strategies to ensure clear communication and inspection readiness.
Safety Database Hosting – Low cost, flexible database system providing regulatory compliant case processing and report generation.
Individual Case Safety Reports (ICSR) Processing – European-based case processing by Health Care Professionals with an average of 11 years of Pharmacovigilance experience focused on:
Signal Detection and Assessment – Healthcare Professional review of individual ICSRs, line listings, aggregate and signal reports to proactively identify trends and signals.
EU-QPPV-support and oversight of client’s portfolio
Our services include:
Safety Management Strategies – Developing project specific Safety Management Plans (SMPs) for drugs, biologics and vaccines and strategies to ensure clear communication and inspection readiness.
Safety Database Hosting – Low cost, flexible database system providing regulatory compliant case processing and report generation.
Individual Case Safety Reports (ICSR) Processing – European-based case processing by Health Care Professionals with an average of 11 years of Pharmacovigilance experience focused on:
- quality
- thoughtful follow-up due diligence
- timely distribution to authorities and partners
Signal Detection and Assessment – Healthcare Professional review of individual ICSRs, line listings, aggregate and signal reports to proactively identify trends and signals.
EU-QPPV-support and oversight of client’s portfolio
Additional Services for Central Eastern Europe (CEE) include:
Teodora Lyuleva
Pharmacovigilance Director
tlyuleva@augustresearch.com
- Provision of National Person Responsible for Pharmacovigilance/local PV contact person / Local Person for Pharmacovigilance (LPPV/ local QPPV) and Deputy; Assurance of 24/7 availability
- Creation and maintenance of local PV systems, including local Pharmacovigilance System Master File (PSMF) and local SOPs
- Managing of safety reports, including follow-up with reporters
- Local implementation of additional Risk Minimization Measures (aRMMs)/ Risk Management Plans (RMPs) including Educational Materials and Direct Healthcare Professional Communication (DHCPs)
- Writing Safety Data Exchange Agreements (SDEAs)
- PV training for local affiliates and/ or distributor’s/ partner staff
- Handling of Regulatory Authority inspections, including CAPA preparation
Teodora Lyuleva
Pharmacovigilance Director
tlyuleva@augustresearch.com