preclinical white papers and articles

  1. 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.

  2. Educating Tomorrow’s Clinical Researchers

    A drug’s journey from proof of concept to FDA approval is a years-long, far-reaching process in which healthcare, business and government each play important roles. For aspiring clinical researchers hoping to navigate this sprawling field, there’s certainly a lot to learn. We thought we’d take a look at a pair of initiatives educating students in healthcare and pharmacology in the many aspects of clinical research. Driving these initiatives is the understanding that clinical research shouldn’t be a niche skill, that strengthening knowledge of clinical research among all kinds of healthcare providers will strengthen the healthcare industry as a whole.

  3. The Importance Of Stakeholder Research In Rare Disease Drug Development

    Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers.

  4. Integrated Workflows: The Unsexy Plumbing Of Clinical Trials

    There is no doubt that clinical research is critical to the advancement of medicine and public health. But conducting such research is a complex, resource intensive endeavor that relies on a multitude of stakeholders, workflows, processes, and information systems.

  5. Advancing Safety and Efficacy Studies with Novel Surgical Applications

    Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery,  novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.

  6. It’s Site Selection, Not a Toss of the Dice

    When shooting craps,odds are 17% that the player will role a 7 to start the action, and the odds of actually winning may be even lower. But, the odds of selecting sites that perform well in clinical trials are worse, far worse. 

  7. Understanding The True Value Of Your Biopharma Product With Earlier Intelligence

    In the initial stages of drug development, it is natural to focus on a compound’s novel mechanism of action and potential implications in a therapeutic area. Yvonne Spark, Consultant, Covance Market Access Services

  8. On-Site Manufacturing In Early Clinical Drug Development (In Europe)

    Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe.

  9. Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs

    Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.

  10. Top Clinical Research Trends of 2014

    2014 was a fast moving, controversial year for the clinical research industry. With so many choices it is hard to provide a complete summary of all of the events or developments over the past year but presented in this white paper is a listing of key topics from 2014. By Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK