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.

Principal investigator and clinical research associate
April 10, 2025
In clinical trials, success hinges not just on protocol design and quality data but on choosing the right investigative sites and engaging them effectively. Here are four key reasons why strategic site selection is critical for maximizing value in your clinical trials.
A car is driving through a tunnel at night.
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.
blog image
December 18, 2024
Since 2018, more than 30 drugs with the potential to impair driving ability have been approved without a dedicated driving study, despite clearly meeting the FDA criteria for such studies based on a conservative application of these criteria.
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