Comprehensive Services for Pharmacovigilance
- Pharmacovigilance data analytics
- Clinical literature review
- Systematic and targeted literature searches
- Screening and selection of relevant publications
- Data extraction and evidence summarization
- Regulatory document support: IB, RMP, CO/CS in CTD, PBRER
- Signal detection in pharmacovigilance
- Gap analysis and scientific contextualization
- Documentation and audit readiness
Consistency You Can Count On
Pharmacovigilance requires a deep understanding of historical data and prior events. Ephicacy’s high staff retention means our clients work with the same experienced professionals year after year. This stability ensures the team knows the context of past events, anticipates future risks, and builds strong working relationships tailored to your culture and communication style.
Breadth of Experience Across Clients & Therapeutic Areas
Internal teams may only see safety signals in the context of their own products. Ephicacy brings a wider lens. Having partnered with top 10 pharma and biotechs across oncology, vaccines, rare diseases, and more, we apply lessons from a variety of contexts to your program. Our exposure to diverse workflows, medical data coding challenges, and regulatory expectations allows us to identify subtle trends and deliver best-in-class pharmacovigilance services.
Targeted Technology Use
AI can accelerate literature review, improve regulatory documentation, and streamline adverse event coding workflows, but only when used strategically. Ephicacy knows where AI adds real value and where it risks generating noise. Combined with our scalable teams in North America and India, this means we can deliver high-volume, high-quality results quickly and reliably, even as your requirements change.
Protect Patient Safety & Maintain Regulatory Compliance
Ephicacy’s pharmacovigilance team combines consistency, breadth of experience, and intelligent technology to deliver safety insights you can trust.
