Our established and proven team delivers scalable, compliant, and robust pharmacovigilance services to clients.
Sustained, consistent, and high-quality delivery
Engagements are led by pharmacovigilance experts who understand the requirements of regulators, client challenges, and the evolving landscape.
Service flexibility and scale
Tailored services to meet clients’ changing needs including flexibility to respond rapidly to project demands and deviations and achieve long-term client loyalty.
Cost effective services
Robust infrastructure with standardized processes supported by tools to monitor workflows, to deliver class-leading efficiency for clients.
Value added clinical safety support services
SAE and SUSAR management
In-house safety database /EDC custom-designed
Solutions for SAE reporting, efficient queries
Efficient reconciliation process
Safety management plan
Highly specialized PV physicians
Expertise in patient safety profile assessments
Safety data listing review and signaling analysis
Large team of clinical senior safety specialists
Medical review and reporting
Trial investigator and Ethics Committee reports
Regulatory authority reports (EU/global)
Signaling, DSUR, and IND Annual reports.
Drug safety took kit
Proactive drug safety planning
SOP development for clinical trial safety
Training design, implementation, and maintenance
Signalling and review of DSURs