Case Study: Acorda Therapeutics, Inc. achieves faster safety insight and streamlined FDA compliance with Oracle Argus Safety (Oracle)

Acorda Therapeutics Improves Safety Insight and Streamlines Regulatory Compliance

Acorda Therapeutics is a biotechnology company focused on therapies for neurological disorders (including the FDA‑approved AMPRYA). Faced with the need to maintain strict FDA pharmacovigilance compliance, the company sought greater control, faster access, and extended visibility into safety data previously managed by a third party, while improving safety‑team productivity, system availability, and reporting flexibility.

Acorda deployed Oracle Argus Safety and Oracle Argus Insight on‑premises with partner Covigilant managing the environment. The solution automated case narratives and workflows, enabled electronic FDA ICSR submission, and put ad‑hoc and performance metrics reporting at the team’s fingertips—resulting in faster, more accurate reporting, deeper visibility into safety signals and trends, improved data quality, and streamlined regulatory compliance.

Acorda Therapeutics, Inc.

Thomas Aquilina

Vice President, Drug Safety and Risk Management