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.
Pharmacovigilance operations
Case processing
ICSR and SAE case processing.
Case intake, triage, data entry, and medical review.
Follow-up and expedited reporting.
Reconciliation.
Literature Management
Search string design and maintenance.
Global and local literature screening.
Medical literature monitoring management.
Article retrieval and assessment tracking.
Integrated
Medical and safety writing
Global clinical and post-marketing periodic reports.
Analysis of similar events.
Risk management reports.
Protocol writing and review (safety sections).
Signal evaluation and risk management
Signal management activities.
Risk benefit analysis.
Risk minimization activities.
Drug Safety Monitoring Board representation.
~1 million
ICSRs / year
99%
Submission compliance
900
Aggregate reports / year
80,000
Monthly citation reviews
43
Countries
