Clinical Trials

  • Clinical Trials
  • Planning a First-In-Human Clinical Trial?


     

    Unique FIH Solutions
    for Small and Large Molecules

    Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.

    This eBook provides an overview of how our unique process can facilitate your early-phase clinical program:

        •   small molecule manufacturing experts quickly formulate your drug product and deliver it to the clinical site, ready for dosing;
        •   coordinated processes between our clinic and our bioanalytical labs;
        •   timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts;
        •   transparent communication between our teams and locations, and strict attention to early-phase timelines; and
        •   a database of over 400,000 normal healthy volunteers and strict safety protocols.

    Access the eBook here to learn more.

    Speak with one of our experts.

    You may also be interested in the following:

    Webpages:

        •   Phase I Clinical Trial Units
        •   First-in-Human Trial Capabilities

    Scientific Journal:

        •   The Advantages of Conducting Early Phase Clinical Research in Canada


     

    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

    GETTING TO THE HEART OF SCIENCE WITH MARTA RODRIGUEZ

    Marta Rodriguez, Director of Clinical Operations at Altasciences
    Marta Rodriguez, Altasciences

    At the heart of science are stories—stories of expe

    A Deep Dive Into the FDA's Psychedelic Clinical Research Guidelines


     

    Decoding FDA Requirements

    Navigating the unique attributes of psychedelic drug development

    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

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    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, 2024Altasciences 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

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