Clinical Trials

  • Clinical Trials
  • Comprehensive Solutions for Your First-in-Human Trials

     

    A Partner You Can Trust

    Altasciences has decades of experience designing, conducting, and reporting on first-in-human (FIH) clinical trials. Simple or complex, we have the expertise, purpose-built Phase I facilities, and seamless processes to deliver quality with speed and ease. Benefit from our customized approach, including clinical pharmacology units and integrated, state-of-the-art bioanalytical laboratories in the U.S. and Canada, along with the full range of complementary services.


    Have a look at these resources to learn more:

    • The Altascientist: 

    Maximizing Drug Formulation for First-in-Human Trials

    Planning Your First-in-Human Trial

     

    ​Have questions? Contact our experts today.

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

     

    You have questions; we have answers.

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    Altasciences
     

    When you need quick answers to your burning questions, simply ask an Altascientist.   

    Chris McEvoy


    How does Altasciences expedite the process for acquiring CITES permits?  
    Watch the video »
    Connect with Chris »

    Scott Boley


    What are the advantages of selecting the miniature swine as a non-rodent model?
    Watch the video »
    Connect with Scott »

    Mathieu Saulnier


    Why is it important to have an in-house team dedicated to bioanalytical equipment?
    Watch the video »
    Connect with Mathieu »

    Lisa Sanford


    Do I need an IND before starting my FIH trial in Canada?
    Watch the video »
    Connect with Lisa »

    Roland Jbeily


    What should sponsors know about Canada’s regulatory requirements for CTA filings?
    Watch the video »
    Connect with Roland »

    Scott Boley


    What factors should sponsors consider when selecting a non-rodent alternative in their nonclinical studies?
    Watch the video »
    Connect with Scott »

    Ben Reed


    What do the recent expansions to Altasciences’ CDMO facility mean for current and future clients?
    Watch the video »
    Connect with Ben »

    Dennis DiBiagio


    How does Altasciences’ manufacturing site support the development of drugs that treat CNS disorders?
    Watch the video »
    Connect with Dennis »

    Submit a question
    See full video series

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
     

    Altasciences has been recognized as a 2023 CRO Leadership Award Champion in the Capabilities category, as voted by you in ISR’s annual CRO Quality Benchmarking survey.

      



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    To You, With Science - Our Latest Audiobook Releases

    Listen to the Latest Audiobook Releases of The Altascientist

    Delve deeper into the critical processes behind early phase drug development with audio versions of The Altascientist, written by our experts with you in mind:

    Issue 31 — The Advantages of Conducting Early Phase Clinical Research in Canada
    Find out you can accelerate your early phase clinical research by six to nine weeks in comparison with trials conducted in the U.S.
    Listen to the audiobook >>>

    Issue 32 — A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies
    Discover the increasing body of evidence that supports the use of miniature swine as a viable option for your small and large molecule studies.
    Listen to the audiobook >>>​​​

    Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity
    Hear about the complexities of CNS drug development programs and how an integrated CRO/CDMO can help move your molecule seamlessly from one phase to the next.
    Listen to the audiobook >>>

     In Case You Missed It: 
    Issue 30 — The Evolution and Advancement of LCMS in Drug Development
    Learn how the latest LC-MS advancements ensure accurate and precise data delivery in your drug development program.
    Listen to the audiobook >>>

    [NEW PODCAST] Exploring the FDA's Draft Guidance on Psychedelic Drug Research

     

    Unlocking New Horizons

    The FDA recently published a first-ever draft guidance on clinical development requirements for psychedelic drugs. 

    Join Altasciences’ panel of experts as they provide an in-depth review of the guidance and valuable insights into the areas where further methodological adaptations to study designs may be necessary. These adaptations play a pivotal role in accurately assessing the safety, pharmacology, and efficacy of groundbreaking psychedelic compounds developed for specific medical applications.

    LISTEN NOW

    FDA Guidenace for Industry Psychedelic Drugs


    You may also be interested in the following:

    •    Webpage: CNS Drug Development Solutions
    •    Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
    •    Webinar: Practical Approaches to Conducting Early Clinical Trials with Psychedelics

    Gain 6 to 9 Weeks by Conducting Trials in Canada

     

    Taking full advantage of Canada's favorable regulatory landscape, Altasciences’ clinical facility in Montréal continues to be a popular choice, successfully completing hundreds of clinical trials each year.

    In this issue of The Altascientist, we discuss the distinct benefits of conducting early phase clinical research on novel compounds in Canada versus other countries.  

     
    DOWNLOAD NOW 

    The Advantages of Conducting Early Phase Clinical Research in Canada

    We cover:
    •    Canadian CTA trials–time and cost savings
    •    regulatory review process predictability
    •    business efficiency cost savings
    •    clinical trial participants
    •    Canadian CTA frequently asked questions
     

    You may also be interested in the following resources: 

    Webpage: Altasciences' Three Clinical Trial Facilities

    Videos:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programmes, to offer an integrated/synchronised approach to CRO and CDMO services.

     

      
     

    An Overview of Health Canada's CTA Process

    Watch this podcast in which Altasciences' regulatory experts share key insights on Health Canada's Clinical Trial Application (CTA) regulatory submission process, including answers to your most common questions.

    Altasciences’ Canadian clinical facility consists of seven Phase I units. We conduct over 100 trials every year in Canada, and support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, and substance abuse.

    Take five minutes to explore these insightful resources

    Accelerating Global Drug Development Timelines With Ethnobridging

    Safe Strategy to Save Time and Money 

    Avoid repeating Phase I studies for drugs intended for the Asian market. Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money. 

    Key resources for ethnobridging in Phase I clinical trials: 

    In this issue of The Altascientist, we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently. Download your copy today

     

     

    In this complimentary webinar, Mel B. Affrime, PharmD, Executive Vice President, Translational Medicine, discusses how ethnic differences can impact the bioavailability of your drug candidate and how to design a multiregional clinical development program to hasten worldwide regulatory approval safely. Watch the webinar.

     

    Speak with an expert today to discuss your next clinical program. 

    You may also be interested in the following webpages:​​​ 

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

    Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines

    Selecting the Right Pain Model for Your Study

    Experience You Can Count On


    With over 25 years of experience, Altasciences offers pain stimulation models and pharmacodynamics tests for early phase analgesic trials. These tests provide critical data for informed decision-making. Our team of pain experts and neuroscientists is here to assist you in selecting the most appropriate pain model to successfully evaluate your study drug's efficacy and safety profile.

    Discover how we can deliver the solutions needed for your pain research.

    DOWNLOAD THE FACT SHEET

    You may also be interested in the following resources:

    • Webinar: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
    • Pain Model Poster: Inside the Pharmacodynamic Toolbox

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    CANADA: A Game Changer for First-in-Human Trials

    Get Ahead of the Competition

    Looking to take your ex-U.S. strategy to the next level? With a state-of-the-art clinical facility in Canada, Altasciences has the capacity and decades of expertise to submit your CTA six to nine weeks earlier than an IND.

    We can help get you into the clinic fasterschedule a chat today!

    Must-watch videos:

    Ophtalmic Early Clinical ResearchCo-located Canadian Ophthalmology Center for All Your Early Phase Development Needs
    Follow Your SampleAccelerate Your Data With Our Canadian Co-located Clinic and Lab 
    Montreal Clinic Mini TourMontréal Clinic Mini Tour
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