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.

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Dementia patient and doctor in clinical setting related to agitation trial

Mastering Agitation Endpoints with Assessment Expertise

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Discover how CRC managed rater complexity and timelines in an agitation study using customized training and algorithmic oversight.
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Seamless Execution Across Early-Phase Alzheimer’s Trials

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Discover how CRC supported a novel Alzheimer’s program through first-in-human (FIH), Phase Ib/IIa, and OLE trials with precision, urgency, and trusted oversight.
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The Expanding Role of GLP-1 Receptor Agonists in CNS Clinical Research

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GLP-1 receptor agonists may offer a new path for treating addiction and mental health challenges, emerging as a versatile class in CNS clinical research.
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