CNS CLINICAL TRIALS
Early development clinical trials for CNS drugs are complex and require in-depth clinical expertise. When conducting CNS clinical trials, it is critical to implement thorough processes in areas such as volunteer eligibility and operational conduct. To meet these demands, CNS study teams should possess both therapeutic and technical expertise.
Altasciences is a leader in the field of early phase Central Nervous System (CNS) clinical trials. Our Principal Investigators, Clinicians, Technical Staff, Nurses, and Management Team have an extensive understanding of psychiatric and neurologic disorders stemming from our decades-long history of conducting complex studies in various therapeutic indications within the Central Nervous System.
We are experienced in adaptive trial designs often associated with CNS therapies and have vast experience working with a central IRBs. Our internal protocol review ensures the protocol is IRB-submission ready, minimizes the risk of amendments and shortens study start-up time.
Distinctive Recruitment Strategies
Our in-house, full-time recruitment team employs effective and efficient recruitment strategies to reliably meet your targeted milestones.
Specialized Secure Pharmacy
Our robust pharmacy capabilities and vast experience include extemporaneous and intravenous preparation (including biologics). Our Pharmacists have extensive experience in preparing and dosing studies via oral, sublingual, intranasal and parenteral routes. Our pharmacy is secured with electronic key fob access, video monitoring and facial recognition technology.
Dedicated Research Physicians
Our Principal Investigators are intricately involved in all aspects of clinical trials, ensuring that proper medical and technical procedures are completed to the highest degree of quality.
ALTASCIENCES' EXPERIENCE IN CNS CLINICAL TRIALS
Over the past 25 years Altasciences has been involved in CNS clinical trials in the following special populations:
Cognitive Testing/Driving Simulation
We have partnered with Cognitive Research Corporation (CRC) to provide sponsors with a state-of-the-art driving simulator study solution to test the impairing effects of a wide variety of drugs on driving abilities in both normal and patient populations. The simulator provides accurate driving performance data comparable in sensitivity to over-the-road-testing, but in less time, for less cost, and with no risk of property damage or injuries. The CRC driving simulator has proven sensitivity to the effects of age, trauma, neurologic disease, drowsiness, CNS depressants and CNS stimulants.
We are proud to have partnered with CRC in establishing the lack of driving impairment following nighttime dosing of flibanserin in premenopausal women. The study, sponsored by Sprout Pharmaceuticals, was described as “reassuring” by the FDA.