CNS Clinical Trials
Early-phase clinical trials for central nervous system (CNS) drugs are highly complex, requiring teams with both therapeutic and technical expertise to address the scientific, operational, and recruitment challenges unique to this field.
With over two decades of experience conducting CNS studies across a wide range of early-phase research areas, our experts deliver the precision, consistency, and speed your program requires.
Clinical Trials for Neurological, Psychiatric, and Cns-Active Compounds
We are a proven CNS Center of Excellence, offering fully integrated, early-phase drug development services designed specifically for the complexities of central nervous system (CNS) therapeutics. With over 30 years of experience and more than 200 CNS studies completed, we support sponsors from preclinical research through clinical proof of concept, all within a single, streamlined organization.
Our CNS expertise spans a broad range of neurological and psychiatric indications, including programs focused on cognition, mood, pain, sleep, and behavioral health. We work across both healthy volunteer and patient populations, using validated models and cognitive assessments to generate high-quality data that drives informed decisions in early pharmacology, safety, and proof-of-concept outcomes.
Led by experienced Principal Investigators, clinicians, and neuroscientists, our team is equipped to design and execute even the most complex early-phase CNS trials. With integrated capabilities in toxicology, clinical pharmacology, bioanalysis, formulation, and manufacturing, Altasciences reduces handoffs, accelerates timelines by up to 40%, and ensures data continuity every step of the way.
From first-in-human (FIH), proof-of-concept (POC), and other clinical pharmacology studies to specialized models―including human abuse liability, pain, driving simulation, and novel CNS compound evaluation―our early-phase capabilities provide the flexibility to evaluate complex CNS programs with precision and confidence.
Consult our CNS Clinical Trials Fact Sheet.
Planning a Cns Trial?
Let’s Do It Right.
We are proud to be recognized as a CNS Center of Excellence—a go-to partner for early-phase CNS development backed by decades of experience and extensive therapeutic insight.
Why choose Altasciences for your CNS program?
- End-to-end, integrated services under one roof
From preclinical safety and toxicology to formulation, manufacturing, bioanalysis, and clinical pharmacology, we integrate all capabilities together. This integration ensures data continuity, minimizes handoffs, and can reduce development timelines by up to 40%. - Specialized CNS expertise and observatory capabilities
With 200+ completed CNS/neurology studies under our belt, we deliver full-spectrum services—e.g., human abuse potential, driving simulation, cognitive assessments, CSF sampling, pain models, and dependence evaluation. - Advanced preclinical and regulatory support
We conduct IND-enabling toxicology and safety pharmacology across species, with experience managing complex CNS programs and psychedelics. Our teams seamlessly guide your program into first-in-human trials with regulatory briefing and support. - Clinical units optimized for CNS trials
Our clinical pharmacology units are DEA licensed, adaptable for psychedelic and CNS trials, and designed for complex assessments, with secure pharmacy systems, flexible inpatient setups, and experienced staff (psychiatrists, neuropsychologists, clinical scientists). We also implement robust recruitment strategies and protocols to keep your milestones on track. - Formulation and manufacturing strengths tailored for CNS
Our cGMP manufacturing facilities are DEA licensed and support CNS products, including handling highly potent or controlled substances. We also use specialized approaches like nanomilling, solubility enhancement, and innovative dosage forms to overcome CNS drug delivery challenges.
ALTASCIENCES’ EXPERIENCE IN CNS CLINICAL TRIALS
Our CNS research portfolio includes a broad range of study types and procedures:
Study Types:
- First-in-human (FIH) with strategic cognitive testing
- Embedded or standalone proof-of-concept (POC)
- Pharmacodynamic (PD)/Pharmacokinetic (PK)
- Human abuse potential (HAP)
- Driving simulation
- Pain models
- Psychedelic drug evaluation
- Respiratory research, capnography
- Sleep efficiency evaluation with polysomnography
CNS-Related Procedures:
- EEG and ERP recordings
- Cerebrospinal fluid (CSF) collection
- CO₂ challenge testing for anxiety models
- Pupillometry
- Electronic visual analog score (VAS)/questionnaires
- Cognitive and psychometric testing batteries
- Biomarkers
- Imaging (e.g., fMRI)
- Regulatory Support
- 8-Factor Analysis
- Briefing books and regulatory meeting preparation
Cognitive Testing and Driving Simulation Studies
Cognitive Testing:
Our expert neuroscientists design and implement targeted neurocognitive assessments to evaluate the effects of medication on brain function. Strategic selection of cognitive markers offers valuable insights into pharmacological safety, performance, and early efficacy signals.
We partner with Cambridge Cognition, a global leader in digital neuroscience technology, to deliver validated, non-invasive test batteries that assess key cognitive domains such as attention, memory, executive function, and psychomotor performance.
Cognitive Domains
- Complex attention
- Learning and memory
- Language
- Executive function
- Social cognition
- Perceptual-motor function
Driving Simulation:
Through our partnership with Cognitive Research Corporation (CRC), we offer state-of-the-art driving simulation studies that assess the effects of drugs on real-world performance in a controlled, low-risk environment. Our on-site simulators provide accurate and reproducible data comparable in sensitivity to on-road testing, at reduced cost and timelines.
Consult our Driving Simulation Fact Sheet for more details.
Ready to Advance Your CNS Program?
Rapid Study Start-up for Your CNS Clinical Trials
Speed and precision are critical in early-phase CNS clinical trials. At Altasciences, our proven start-up process is built to accelerate timelines while maintaining the highest standards of quality and compliance. From contracting and regulatory submissions to participant recruitment, our dedicated CNS teams manage every detail—ensuring fast, coordinated execution.
We reduce study start-up time through:
- Efficient regulatory preparation and contracting workflows
- Dual project management to align sponsor and site timelines
- Strong communication strategies that keep all stakeholders informed
- Rapid recruitment supported by purpose-built CNS databases
Our start-up approach includes:
- Development of customized SOPs specific to your protocol
- Rigorous training for staff and participants to ensure data consistency and protocol adherence
- Practice sessions to confirm participant understanding and compliance before dosing
- Extensive experience working with central IRBs, adaptive trial designs, and global submission standards
We help ensure your protocol is submission-ready, reducing the risk of amendments and speeding regulatory approval.
With three clinical pharmacology units and co-located bioanalytical labs across the U.S. and Canada, Altasciences offers multiple regulatory pathways to meet your needs:
- IND (Investigational New Drug) applications in the U.S.
- CTA (Clinical Trial Application) support for Canada and Europe
Our cross-border infrastructure provides the flexibility, scalability, and speed your CNS program needs to advance with confidence.
SPECIALIZED RECRUITMENT STRATEGIES FOR CNS TRIALS
Whether your study requires healthy volunteers, aging populations, or patients with specific CNS disorders—such as Alzheimer’s, Parkinson’s, depression, or anxiety, we offer reliable access to qualified subject pools through our established recruitment network.
With a database of over 400,000 participants across our sites, we enable precise and efficient enrollment tailored to the needs of CNS research. Backed by extensive experience in CNS clinical trials, our teams understand the nuanced participant profiles each study demands and ensure individuals are thoroughly screened to deliver dependable, high-quality data.
Special Population and Patient Access
Through our internal resources and extended network of hospitals and clinics, we can identify and enroll specialized or patient cohorts for early-phase CNS studies, including participants diagnosed with:
- DHD
- Epilepsy
- Migraine
- Pain
- Neuropathies
- Restless leg syndrome
- Age-related cognition issues
- Sleep disorders
- Anxiety and panic disorders
- Major depressive disorder
- Fibromyalgia
- Premenstrual dysphoric disorder
- Binge eating disorder
- Osteoarthritis
- Substance use disorders
Patients with other CNS disorders can be identified upon request.
Participant Safety Measures
Our facility and study processes prioritize participant comfort and reliable study conduct to ensure high-quality CNS data, utilizing clear communication and continuous medical oversight to maintain retention and consistency.
Participant Safety Measures
- Feasibility/risk assessment – from receipt of first requirements until study completion
- The investigator assesses participants daily
- 24/7 Advanced Cardiac Life Support (ACLS) provider coverage on-site
- Basic Cardiac Life Support certification for all clinical staff
- Crash carts on-site
- Scenario-based response training
- Telemetry with pulse oximetry
- Strategically placed panic buttons
From Design to Delivery—Full-Service Partner for Your Cns Trials
We offer fully integrated, turnkey solutions for CNS studies in healthy participants or patients, managing every aspect of your trial from start to finish.
Protocol review/writing
Whether developing a protocol from scratch or optimizing an existing one, our clinical and scientific experts streamline every step to enable informed decisions and achieve critical study milestones. With extensive expertise in early-phase CNS research, we design regulatory-compliant studies tailored to your compound’s pharmacology, safety profile, and pharmacodynamic objectives.
Clinical Conduct:
Our three state-of-the-art clinical pharmacology units across North America are fully equipped for CNS trials, with specialized teams overseeing dosing, sampling, cognitive and psychometric testing, and pharmacodynamic assessments in controlled environments.
- Customized Facilities:
Our clinical units are purpose-built to support controlled cognitive testing environments. Light, temperature, and sound are carefully regulated to minimize distractions and ensure valid, reproducible results. Participants are continuously monitored to maintain safety and consistency during all assessments. - Specialized Secure Pharmacy:
Our fully licensed pharmacies are authorized to handle all Schedules of controlled investigational compounds and support the preparation of extemporaneous and intravenous preparations, including biologics. Secure storage and controlled access systems ensure full compliance with DEA and Health Canada requirements.
CRA/Clinical monitoring:
Real-time oversight of PK/PD data, safety evaluations, and adverse event reporting ensures compliance with regulatory expectations and preserves data integrity throughout your study.
Bioanalytical Services:
Our co-located bioanalytical laboratories offer validated assays for CNS compounds and biomarkers. We deliver precise and timely PK/PD data, enabling faster, informed decision-making and supporting comprehensive regulatory submissions.
Data Services and Reporting:
We manage data collection, statistical analysis, and full reporting to deliver reliable results that meet stringent regulatory and scientific standards.
Regulatory Consulting:
Our regulatory experts provide guidance through all stages of CNS development, from early-phase protocols to submissions requiring specific safety or scheduling evaluations.
We will ensure your CNS clinical study is fully enrolled with the right participants, conduct it, and deliver the data on time.
Partner with Altasciences for CNS Drug Development
Whether you're developing a novel CNS compound or repurposing an existing molecule, we provide the expertise, infrastructure, and patient access needed to navigate the complexity of CNS clinical development.
With over 30 years of proven CNS experience, we are more than just a CRO/CDMO; we are your partner in advancing neuroscience.
Contact us today to learn how we can support your CNS drug development program—from end to end.
