IND to FDA Approval: Acute Agitation in Schizophrenia and Bipolar Disorders

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.