Preclinical Studies

PRECLINICAL STUDIES WHITE PAPER & ARTICLES

  • Phase I Studies: From First Drug Design To First-In-Human Studies
    Phase I Studies: From First Drug Design To First-In-Human Studies

    Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.

  • Precision Medicine In Immuno-Oncology
    Precision Medicine In Immuno-Oncology

    The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.

  • What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?
    What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?

    Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.

  • 3 Early Obstacles In Phase I Clinical Trials, And How To Address Them
    3 Early Obstacles In Phase I Clinical Trials, And How To Address Them

    Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall by the wayside suffer that fate because of unfavorable efficacy data in the middle and later phases.

  • Avoiding Headaches In Today’s Complex Phase I Landscape
    Avoiding Headaches In Today’s Complex Phase I Landscape

    Statistics suggest that Phase I clinical trials, while by no means free of challenges, are more manageable than later phases. They tend to take less time and cost less money; the drugs they test have a comfortable 70% chance of moving on to the next phase.(1) These figures are a reprieve from some of the realities that make Phase I trials, in some respects, uniquely stressful. The absence of a safety profile for the drug being tested can make subject recruitment particularly challenging. And any errors or delays in Phase I can set the tone for the rest of the drug development process.

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PRECLINICAL APPLICATIONS & STUDIES

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PRECLINICAL PRODUCTS AND SERVICES

Rare Disease And Orphan Drug Research Rare Disease And Orphan Drug Research

While developing drugs to treat rare diseases is more viable from a business perspective than ever before, the clinical research and go-to-market planning process is still fraught with challenges. Regulations, protocols, logistics, and reporting are all different when patients are scarce, the stakes are high, and treatments are complex.

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PRECLINICAL SUPPLIERS

  • PRA Health Sciences
    PRA Health Sciences

    PRA is a global Clinical Research Organization providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on 6 continents through our global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enable our project teams to deliver consistent and on time performance for our clients.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

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