Clinical Trials
Top 5 Scientific Resources in CNS Clinical Trials
CNS Center of Excellence Resource Library
Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.
Here are some of our most insightful scientific resources in the area of CNS drug development:
Webinar: A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development
Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential. Watch Now
The Altascientist: Central Nervous System
Early-phase development of CNS-acting drugs is a complex, challenging undertaking.
In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development. Learn More
The Altascientist: CNS, Psychedelics, and Other Schedule I Drugs
In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More
The Altascientist: Studying the Effects of Drugs on Driving
Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More
The Altascientist: Human Abuse Potential Studies
The 2017 FDA guidance states that a broad range of CNS drugs require human abuse potential (HAP) studies to evaluate the abuse liability of drugs in development before a drug reaches the market. The complicated regulatory pathway for HAP requires individualized consulting for each type of study. Watch Now
Speak with an expert today to learn more about our CNS solution.
Have five more minutes? Check out these webpages:
• CNS Clinical Trials
• Human Abuse Potential<
• Driving Simulation<
First-in-Human Solution for Small and Large Molecules
Healing Hearts: A Journey of Compassion and Commitment
GETTING TO THE HEART OF SCIENCE WITH MARTA RODRIGUEZ
At the heart of science are stories—stories of expe
A Deep Dive Into the FDA's Psychedelic Clinical Research Guidelines
Decoding FDA Requirements
Watch as Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential.
Topics covered:
• important FDA recommendations;
• clinical methods to optimize early-phase clinical trials with psychedelics;
• how to address the abuse potential evaluation requirement for psychedelic drugs; and
• strategies to ensure study integrity.
You may also be interested in the following resources:
• Webpage: CNS Drug Development Solutions
• Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
• Webinar: Practical Approaches to Conducting Early Clinical Trials with Psychedelics
Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials
Over 20,000 FDA-approved drugs are currently on the market, and many contain psychoactive or sedative pharmaceutical ingredients that can alter the ability to operate a motor vehicle, making reducing the incidence of motor vehicle accidents (MVAs) caused by drug-impaired driving a public health priority.
Discover the Power of Driving Simulations for CNS Side-Effect Analysis
Start Your Driving Trial Quickly—Simulators On-Site
Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. This issue of The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offers:
Faster study startup • Lower cost • No risk of property damage • No risk of injuries
This issue includes a case study for which the results were described as “reassuring” by the FDA.
Altasciences has conducted over 13,000 simulated drives in support of drug development.
Download as a PDF or listen to the audiobook; the choice is yours.
You may also be interested in the following:
• Driving Studies Webpage
• Driving Studies Webinar
Altasciences Appoints New General Manager, Clinical Operations
Laval, Québec, Monday, January 29, 2024—Altasciences announced the appointment of James Brazeal as General Manager, Clinical Operations, at its clinical facility in Kansas City.
James joined Altasciences, having previously worked as Vice President of Research at Akron Children’s Hospital, and most recently as Vice President of Research Operations for Circuit Clinical.
“James’ proven leadership skills, and deep knowledge of all phases of clinical research, will be invaluable in delivering expert guidance for our clients along their early-phase clinical journey,” said Ingrid Holmes, Vice President, Clinical Operations, Altasciences.
With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City.
“It is rewarding to be joining a team that has been in place for almost three decades, a team committed to quality, excellence, integrity, and respect—focused on helping to bring better therapies to the patients who need them, faster,” says James.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Regulatory Comparisons for Starting First-In-Human Clinical Trials
A Closer Look At Our On-Site Compounding Pharmacies
Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards.
What you can expect:
Cutting-Edge Facilities
- USP 797 certified clean rooms with Class II biological safety cabinets.
- Negative pressure, HEPA-filtered extemporaneous compounding rooms equipped with the advanced PowderSafe™ ductless balance enclosure, guaranteeing sterile and controlled environments for multiple dosage forms.
- Electronic security access to the pharmacy and video monitoring.
- 24/7 monitoring of temperature and humidity.
Regulatory Excellence
- Licenses for Schedule I through IV drug substances.
- Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units.
- Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.
Comprehensive Capabilities
- Extensive experience in extemporaneous and intravenous preparation, including biologics.
- Fully equipped to support all types of IP administration forms.
Clinical Supply Manufacturing
Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.
You may also be interested in the following webpages:
Pharmaceutical CDMO and Contract Manufacturing Services
DID YOU KNOW?
Our CDMO team offers formulation development and manufacturing of your API, from discovery through commercialization. We also provide analytical testing, ICH stability storage and testing, as well as finished product and release testing. We can manufacture almost every dosage form on the market.
Start Your Clinical Trials Faster... 70% Faster!
The Secret to Accelerated
Drug Development
Our latest case study showcases how we started a Phase I study in just 3.5 weeks, 70% quicker than the industry’s 12-week standard.
The secret to our success? Effective communication, strategic planning, optimal delegation of responsibilities, and removal of silos.
We aligned our internal team on all objectives, engaged in open dialogue with the sponsor throughout the study, and optimized project management by assigning two leads in two different time zones—expediting decision-making. This case study is your roadmap to faster drug development.
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Contact us to discuss how we can accelerate your study start-up timelines.