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Driving CNS Clinical Trial Success Through Data Confidence

In an industry where nearly half of Phase III CNS studies fail to show treatment group separation, data confidence to make reliable inferences and decisions is paramount. Trust Signant's 25+ years of proven expertise in helping sponsors optimize their signal detection potential in CNS drug development programs.

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Unrivaled CNS trial leadership

1300+
CNS TRIALS

68K+
RESEARCH SITES

70+
INDICATIONS

380K+
PATIENTS

70+
LANGUAGES

CNS trial challenges:
The critical factors affecting success

Watch: How We Overcome CNS Trial Challenges (4min)

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High Placebo Response

Masks true treatment effects and can lead to failed trials despite potentially effective treatments.

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Variability in Outcome Measures

Inter- and intra-rater variability introduces noise that makes it difficult to detect treatment intervention effects.

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Baseline Score Inflation

Results in inappropriate patient inclusion, adds to placebo response, and makes it harder to demonstrate treatment group differences when they exist.

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A Multi-Layered Challenge 

These factors interact and compound each other, creating complex challenges that require comprehensive solutions for optimal signal detection. Traditional approaches often fail by addressing only single aspects.

The 7 critical pillars for CNS trial success 

Signant's 7-Pillar framework is specifically designed to address these interrelated challenges through a comprehensive, integrated approach. By targeting each critical factor from multiple angles, we create a robust foundation for endpoint reliability and data confidence. 

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SITE SELECTION
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RATER STATION®
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CENTRAL RATING & CENTRAL REVIEW
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The Signant 4S Advantage

Solution

Our purpose-built Rater Station® platform addresses the complexities of CNS clinician-rated assessments with intelligent workflows and on-screen guidance that enhance endpoint reliability.

Science

Our in-house team includes renowned psychiatrists and neurologists who pioneered many of today's gold-standard rating scales.

Scale

With experience across 60+ countries, we support studies of any size, from targeted rare disease trials to large global programs.

Service

Our expert teams deliver exceptional support throughout the entire study lifecycle with deep understanding of CNS-specific challenges.

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Comprehensive expertise and therapeutic coverage 

Our expertise spans the entire CNS landscape, encompassing both common and rare neurological and psychiatric conditions.  

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Neurology

In neurology, we've supported groundbreaking research from large-scale Alzheimer's trials spanning hundreds of sites across 40+ countries to specialized studies in rare conditions like Rett Syndrome and ALS.

Psychiatry

Our psychiatry experience is equally robust, with particular depth in schizophrenia across 60+ countries, treatment-resistant depression, and numerous mood and anxiety disorders.


With experience managing trials involving over 100,000 patients in a single indication and navigating the complexities of 50+ languages, we bring unparalleled depth and breadth of expertise to CNS clinical research. This comprehensive expertise allows us to anticipate challenges specific to each indication and implement targeted strategies that maximize signal detection and optimize trial outcomes. 

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CNS trial success in action

Advancing CNS research standards 

Beyond delivering solutions for individual studies, Signant actively contributes to the advancement of CNS research methodology. Our team of 50+ in-house experts includes recognized authorities in neurology, psychiatry, and clinical assessment who collaborate with leading regulatory bodies and industry consortia to develop and refine approaches that drive higher quality data across the field. This scientific leadership ensures our solutions incorporate the latest advancements in CNS clinical evaluation.

Meet Our Scientific Experts

Our Approach 

Signant's 7-Pillar framework is specifically designed to address these interrelated challenges through a comprehensive, integrated approach. By targeting each critical factor from multiple angles, we create a robust foundation for endpoint reliability and data confidence. 

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eCOA & Electronic Clinician Ratings

With dozens of built-in electronic neurology and psychiatry clinical outcome assessments, our eCOA platform minimizes rater errors by applying internal logic, edit checks, audio/video recording capability, and on-screen guidance to facilitate ensure accurate, reliable COA data.    

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Placebo Response Mitigation

Limit the impact of placebo response on study success through protocol-specific training for investigators, site staff, and patients delivered by Signant clinicians.  Our training is proven to lower the impact of placebo response, driving cleaner assessments of treatment effects.


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Rater Training & Certification

Leveraging our direct experience in CNS trials, our experts qualify, train, certify, and recalibrate raters throughout your studies to ensure consistency, accuracy, and standardization. Our technology enables gatekeeping of raters by qualification status to further safeguard study data. 

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PureSignal Analytics

A must-have component to any CNS study, Signant’s unique solution blends custom analytics tailored to your study endpoints with clinically driven interpretation and intervention, helping sponsors proactively mitigate COA data risks before they impact signal detection.

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Central Review

Access a network of specialized, experienced raters who perform independent reviews of recorded assessments to validate scoring and administration consistency and accuracy, ensuring COA data reliability.

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Scientific Consulting

Our unrivaled and highly-experienced team of CNS science and medicine professionals, as well as clinical trial technology and operations experts, actively partner with study teams from launch to closeout to optimize clinical data quality and CNS study outcomes.   

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FAQ

What solutions does Signant offer for CNS clinical trials?

Signant provides a comprehensive suite of solutions including electronic Clinical Outcome Assessments (eCOA), Rater Station®, rater training & qualification, central ratings & central review, endpoint quality monitoring through PureSignal Analytics, and placebo response mitigation strategies - all tailored specifically for CNS trials.

How do you ensure data quality in CNS trials?

Our multi-factorial approach combines our intelligent eCOA platform, expert rater training, and real-time endpoint quality monitoring. PureSignal Analytics identifies potential data quality concerns early, enabling prompt intervention.

How can you help reduce placebo response in our CNS trial?

Our comprehensive placebo response mitigation strategy combines specialized rater training, endpoint quality monitoring, and proven assessment methodologies to maintain data integrity throughout your study. This approach addresses both genuine placebo effects and data quality issues that can mimic placebo response

What experience do you have with central ratings for psychiatry studies?

Our central rating program includes a network of qualified psychiatrists and clinical assessors specialized in key psychiatric scales like PANSS, MADRS, and HAM-D.

Can you support remote assessments for our CNS trial? 

Yes, our platform fully supports both hybrid and fully remote CNS trials with validated solutions for remote data capture and video assessments. 

How do you handle rater training for global CNS studies? 

We deliver multilingual rater training and certification programs that account for cultural differences while maintaining consistent assessment standards. Our approach includes comprehensive qualification, ongoing calibration, and real-time performance monitoring to ensure reliable data collection across all study regions. 

Do you support complex adaptive trial designs for CNS studies? 

Yes, our platform is designed to handle adaptive trial designs, including basket trials and master protocols. We provide flexible randomization systems, real-time endpoint monitoring, and rapid implementation of protocol adjustments to support your adaptive trial needs. 

Drive Your CNS Trial Success 

Partner with Signant Health to navigate the complexities of CNS clinical research with confidence. 

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