Clinical Trials

  • Clinical Trials
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    A History of Public Attitude Towards Psychedelic Drugs 

    Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag

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    Determining the impact that a medication may have on driving ability is an important safety determination in

     

    From trial sites to our labs, Altasciences’ Material Management Team has over 25 years of experience supporting clinical trials around the globe. We make it easy with efficient collection, preparation and shipment of clinical samples.

    Each kit is adapted to your specific study needs, and allows for the storage and shipping of different matrices, such as plasma, urine, serum, and whole blood.

    Download our fact sheet to learn more about our capability or
    send us an e-mail and we will connect you with an expert within 24 hours.

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

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    Webpages:

    Fact Sheet:

    Psychedelics — A New Era of Modern Medicine

     

    The potential use of psychedelics for the treatment of various CNS indications is filling the drug development pipeline. Researchers in the field are examining modified chemical structures and analogs to psychedelics, to demonstrate efficacy and mitigate potential side effects.

    In this podcast, Altasciences’ and DevelRx’s scientific experts examine the preclinical, clinical, and regulatory requirements and strategies that second-generation psychedelics may utilize to differentiate their pharmacological profile. We examine how to demonstrate efficacy and generate safety data that may distinguish psychedelics from first generation candidates. 

    Listen now

    The Next Trip

    Speak with an expert about your research needs.

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

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    Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiat

    How Is Partnering with Altasciences for Your First-in-Human Clinical Trials Different?

    Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone in your drug development program. Altasciences is here to help you get there, conduct your study, and provide you with a full range of complementary services.  

    A Different Kind of CRO

    Altasciences offers a unique integrated approach that can reduce program timelines by as much as 40%, lowering costs and getting better drugs to the people who need them, faster.

    • Regulatory expertise
      o   Our regulatory advisors have extensive experience navigating complex regulatory processes, ensuring your IND and CTA applications are submitted and processed swiftly and efficiently.
    • Scientific and operational expertise
      o   You can trust our team to deliver high-quality, customized solutions for your clinical trial needs.   
    • Pharmaceutical manufacturing
      o   We offer a wide range of manufacturing services to support your preclinical and clinical trials.
    • Bioanalysis
      o   With over 200 highly trained specialists and a capacity of over 60K study samples per month, Altasciences has the capacity to process your data quickly.
    • Project management

     

     

     

     

    A single, dedicated project manager, along with a proprietary information-sharing database, means you only have to Tell Us OnceTM. Learn more about Altasciences’ FIH solutions.

     

    Speak with one of our experts.

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Let’s Talk Integrated Clinical and CDMO Solutions

     

    Quality and Excellence with Integrated Clinical and CDMO Solutions

    Shawn Connaghan, Executive Vice President of Administration and Quality Management, Manufacturing, discusses how Altasciences’ integrated manufacturing and clinical solutions can benefit your drug development program. 

    Topics covered:

    • Advantages of integrated manufacturing and clinical solutions
    • Quick project start-up
    • Maintaining high-quality standards
    • Adapting to sponsors’ unique needs

    WATCH NOW

    Quick Chat with Shawn Connaghan, Executive Vice President of Administration and Quality Management

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Expert Support for Your IND/CTA Requirements

    Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.

    Contact our experts today.

    Altasciences can help you compile the key information necessary to approve your application request, including:

    • Animal pharmacology and toxicology studies to assess safety
    • Manufacturing processes to ensure consistent batches of the study drug
    • Clinical protocols and investigator information to assess tolerance and risk

    For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.

    Altasciences’ Proactive Drug Development platform transforms the traditional outsourcing paradigm by providing you with expertly designed, customized roadmaps that seamlessly bring you from lead candidate selection to clinical proof of concept, and beyond.

    You may also be interested in the following:

    The Many Faces of Recreational Drug Use: A New Podcast Series

     

    Prescription drug abuse is a serious public health concern that has been exacerbated by the stress of living through the COVID-19 pandemic. Behind this troubling trend are individual people, each with their own story to share.

    Altasciences recently launched a podcast series, The Many Faces of Recreational Drug Use, to provide insight into the personal experiences of individuals who abuse opioids and stimulants. Hosted by Altasciences’ Chief Scientific Officer, Dr. Beatrice Setnik, with expert commentary by Psychiatrist and Senior Principal Investigator, Dr. Debra Kelsh, the first episode provides a candid discussion of some of the hopes and challenges experienced by those who struggle with drug abuse.

    See the first episode.

    Speak with an expert about your research needs.

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    The Bioequivalence of Fixed-Dose Combination Tablets of Bisoprolol and Ramipril and its Drug-Drug Interaction Potential

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