IND to FDA Approval: Acute Agitation in Schizophrenia and Bipolar Disorders
September 17, 2024
Overcoming Obstacles to Bring a New Standard of Care
Discover how CRC’s approach helped a biopharma company secure FDA approval for a novel treatment targeting acute agitation in schizophrenia and bipolar disorders. With strong site relationships, rigorous rater training, and expert regulatory guidance, the project team successfully navigated complex conditions, including the challenges posed by the COVID-19 pandemic.

March 26, 2025
Discover how CRC leveraged our proprietary driving simulator to swiftly complete a next-day effects study in support of a multinational Pharma Company's NDA submission. This case study showcases our ability to navigate complex clinical challenges under tight timelines, finishing 11 days ahead of schedule and exceeding project expectations.