Safety

Our pharmacovigilance services are accepted by FDA and tailored to the needs of each client.

Our Approach

  • 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:
Corrona safety data collection process

Advantages

  • 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.