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.