When it comes to Neurological and Psychiatric clinical trials, history would have us believe the future is going to be mired in more of the same – failure.

Over the past decade, 99% of Alzheimer’s drug trials have failed and the likelihood of approval in neuropsychiatry indications is barely 6%. And with nearly a quarter of all Americans having at least one CNS disorder and the majority of effective treatments dating back to the 1950s, the need for better CNS disease research solutions is clear.

The way we see it, past failure isn’t a problem. It’s an opportunity.

An opportunity to ask ‘why?’ When history tells us that participant compliance is one of the biggest challenges to the success of any CNS clinical trial, we listen, learn, and adapt.

An opportunity to improve participant retention and study adherence by creating a trial experience that’s adaptable and as smooth as possible. By incorporating patient and caregiver needs and concerns into the initial study design process, as well as decentralized clinical trial needs, we are able to mitigate and minimize their burden before it becomes a problem – ensuring participants are fully engaged at each and every stage of the CNS trial process.

An opportunity to unite our team of experts. With over 130 years of central nervous system experience including more than 330 clinical studies, 3,000 sites and 70,000 patients, no matter what challenges may arise during the development of your drug … our team of experts stand ready to utilize their learnings to enhance the success of your drug development program.

An opportunity to utilize the past to advance our future. Our cross-functional collaborative approach allows us to identify challenges earlier, de-risk your development strategy, and eliminate the missteps and delays often caused by silos and handoffs – ultimately ensuring a consistent program that’s flexible and runs smarter and more efficiently.

An opportunity to set a higher standard for neuroscience research by overcoming past challenges and accelerating the patient path to relief and your path to approval.

And the perfect opportunity to do what we do best – create a better experience for our partners within their CNS therapy area.

Why Choose Rho?

• More than a dozen articles in the area of CNS clinical research in prestigious peer-reviewed journals, including The Journal of the American Medical Association (JAMA), The Lancet Neurology, The Journal of Pediatric Psychology, and The Journal of the International Neuropsychological Society.
• An outstanding track record starting up and executing CNS clinical trials
• Excellent relationships with successful sites that will help you meet your enrollment goals
• Expertise managing and distributing Schedule II drugs
• Experience at FDA meetings handling missing data problems—a common issue in CNS trials because of study dropouts and missed assessment

Several successful 505(b)(1) submissions

3 recent 505(b)(2) submissions