13 episodes

Altasciences is a forward-thinking, mid-size contract research organization 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’ full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

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    • Science
    • 5.0 • 2 Ratings

Altasciences is a forward-thinking, mid-size contract research organization 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’ full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

    EPISODE #13: Comparison of US FDA and Health Canada CTA submission

    EPISODE #13: Comparison of US FDA and Health Canada CTA submission

    Paul Sidney, Senior Director, Compliance and Regulatory Affairs, and Dr. Joe Francisco, Chief Toxicologist, present a comparison of the U.S. FDA and Health Canada CTA submission process to support first-in-human phase I clinical trials.

    Learn more about:
    • How data from nonclinical studies in support of an IND submissions is submitted to foreign receiving authorities
    • The Clinical Trial Application review process (what to include and expected timelines)
    • The differences and similarities between the U.S. FDA and Health Canada

    • 1 hr 7 min
    EPISODE #12 - Transitioning Novel Scientific Workflows To Routine Bioanalysis

    EPISODE #12 - Transitioning Novel Scientific Workflows To Routine Bioanalysis

    Interview with Dr. Anahita Keyhani, Altasciences with Mike Lee and Neil Spooner from CPSA Everyday

    • 35 min
    EPISODE #11: Overcoming the Challenges of Manufacturing and Clinical Trials

    EPISODE #11: Overcoming the Challenges of Manufacturing and Clinical Trials

    EPISODE #11: Overcoming the Challenges of Manufacturing and Clinical Trials by Altasciences

    • 59 min
    EPISODE #10: Requirements for Preclinical Testing of Cannabinoid Drug Products

    EPISODE #10: Requirements for Preclinical Testing of Cannabinoid Drug Products

    EPISODE #10: Requirements for Preclinical Testing of Cannabinoid Drug Products by Altasciences

    • 18 min
    EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring

    EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring

    EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring by Altasciences

    • 9 min
    EPISODE #8 - Cannabis and Clinical Trials Overview with Dr. Beatrice Setnik and Ingrid Holmes

    EPISODE #8 - Cannabis and Clinical Trials Overview with Dr. Beatrice Setnik and Ingrid Holmes

    EPISODE #8 - Cannabis and Clinical Trials Overview with Dr. Beatrice Setnik and Ingrid Holmes by Altasciences

    • 30 min

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