Our pharmacovigilance services are accepted by FDA and tailored to the needs of each client.
- Established framework - used to satisfy FDA post-authorization safety surveillance requirements for five major therapeutic agents in psoriasis and rheumatoid arthritis.
- Reporting customized to subscriber and regulatory agency requests.
- Safety data are collected in a carefully monitored process:
- Independence increasingly valued by regulators and the medical community.
- Data pooling of multiple cohorts provides scientific depth and a robust sample (e.g. TNF-I, IL-12/23, IL-17).
- Credibility with the scientific community and by top-tier journals, without the perceived bias of pharmaceutical company sponsored registries.
- Ability to contextualize safety rates among multiple comparator arms.
- Validated outcome measures collected from provider and patient.