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Preclinical

The first step of moving a product from the lab to marketplace is in preclinical. Prior to testing a product in human trials, extensive preclinical studies must be performed 
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The Omni-EDS structure and focus enables us to determine the optimum strategy for your compound. Our preclinical experts work with early stage projects and help shepherd them through the preclinical process. Omni-EDS preclinical expertise assists clients in providing the necessary data to empower next steps and gain regulatory approval. We can help coordinate your project's preclinical activity so it enables and empowers a successful clinical program. 
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Omni-EDS has the scientific and technical expertise to handle most preclinical drug discovery needs. Every study we design and manage is based on proven models specifically tailored for the intended drug compound to meet specific needs and regulatory acceptance.  Using your drug compound and our scientific expertise, we deliver timely, actionable preclinical research data. 
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The primary goal of toxicology studies is to assess the safety risk of drugs by translating the animal model results into a better understanding of the human subject risk.  Omni-EDS toxicologists are well versed in international guidelines for safety evaluation, as well as traditional and nontraditional toxicology models.  We assist our clients identifying relevant animal toxicology models and validated procedures to ensure your data is actionable and submitable to regulatory authorities.
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At Omni-EDS, we can help you decide which trials you should do and where you should do those trials. Omni-EDS’ preclinical experts understand that preclinical studies should be designed around the goal to move a product into the clinical stage. Our experts look for ways to minimize the necessary trials and maximize the utility of the preclinical data. At Omni-EDS, we can help you decide which trials you should do and where you should do those trials. 
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  • Home
  • Drug Development
    • Pre-clinical
    • CMC
    • Clinical
  • Regulatory
    • Strategy & Representation
    • Operations
    • Submissions
  • Medical Writing
    • Regulatory & Clinical
    • Scientific Grant
    • Scientific Manuscript