13 episodes
Altasciences Altasciences
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- Science
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5.0 • 2 Ratings
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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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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 -
EPISODE #12 - Transitioning Novel Scientific Workflows To Routine Bioanalysis
Interview with Dr. Anahita Keyhani, Altasciences with Mike Lee and Neil Spooner from CPSA Everyday
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EPISODE #11: Overcoming the Challenges of Manufacturing and Clinical Trials
EPISODE #11: Overcoming the Challenges of Manufacturing and Clinical Trials by Altasciences
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EPISODE #10: Requirements for Preclinical Testing of Cannabinoid Drug Products
EPISODE #10: Requirements for Preclinical Testing of Cannabinoid Drug Products by Altasciences
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EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring
EPISODE #9: Choosing the Right CRO for your Clinical Trial Monitoring by Altasciences
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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