Author: Karen McCusker

  • Is the UK on its way to becoming a first-class choice for commercial clinical research?

    Is the UK on its way to becoming a first-class choice for commercial clinical research?

    One year after the UK’s biggest overhaul of clinical trial regulation in 20 years, is the UK on its way to becoming a first-class choice for commercial clinical research? Legislative changes to streamline clinical trial approvals were announced by the MHRA in March 2023, promising the biggest overhaul of UK regulation in 20 years to…

  • What are Early Phase Clinical Trials?

    What are Early Phase Clinical Trials?

    Early phase clinical trials are the first stage of testing a new medical treatment, drug, or device in human subjects. The focus of these trials in clinical development is to determine the safety and tolerability of the treatment, as well as to identify any potential side effects. You might also be interested in learning more…

  • Rare diseases: Your questions answered

    Rare diseases: Your questions answered

    Rare diseases cover a huge range of different, specific diseases and conditions. We’ve pulled together some of the most common questions on rare diseases and orphan drugs to give you a better understanding of this important topic. If you want to read even more information, try our comprehensive blog: rare diseases: everything you need to…

  • The Importance of Healthy Volunteers in Clinical Trials

    The Importance of Healthy Volunteers in Clinical Trials

    Clinical trials play a pivotal role in advancing medical research and developing new treatments. At the heart of these trials are healthy volunteers, individuals who willingly participate in clinical research to drive medical advancements.  In this article, we explore the significance of healthy volunteers in clinical trials and their impact on drug development. What are…

  • Clinical Considerations for First-in-Human Clinical Trials

    Clinical Considerations for First-in-Human Clinical Trials

    First in Human clinical trials play a crucial role in ushering investigational new drugs or interventions into clinical practice. First in Human trials, follow preclinical testing, using in vitro and in vivo experimental models to ensure the safety of participants. The process involves four phases, with drug candidates typically gaining approval after the third phase…

  • How can AI improve patient outcomes in clinical trials?

    How can AI improve patient outcomes in clinical trials?

    Welcome back to our blog series where we share some of the highlights and key takeaways from our fireside chat with CEO of Simbec-Orion, Fabrice Chartier, and CEO of biotx.ai, Joern Klinger. Our last blog post covered whether AI can help with achieving orphan drug status, recent trends in clinical trial design, how AI can…

  • Can AI help with achieving orphan drug status?

    Can AI help with achieving orphan drug status?

    Welcome back to our blog series where we share some of the highlights and key takeaways from our fireside chat with CEO of Simbec-Orion, Fabrice Chartier, and CEO of biotx.ai, Joern Klinger. Our last blog post covered how AI can demonstrate the potential of the pipeline to investors and how AI could disrupt clinical development…

  • How does AI-enabled causal modelling support discussions with potential investors?

    How does AI-enabled causal modelling support discussions with potential investors?

    Welcome back to our blog series where we share some of the highlights and key takeaways from our fireside chat with CEO of Simbec-Orion, Fabrice Chartier, and CEO of biotx.ai, Joern Klinger. Our last blog post covered what AI-enabled causal modelling is, how it is different from other models, and where you might want to…

  • Can early utilisation of AI-enabled causal modelling de-risk and accelerate clinical development?

    Can early utilisation of AI-enabled causal modelling de-risk and accelerate clinical development?

    Can early utilisation of AI de-risk and accelerate clinical development for drug developers? Recent announcements suggest large pharma companies are betting big on AI. AstraZeneca recently announced a $247 million deal with an AI vendor to support identifying new oncology drug candidates[1]. Sanofi has announced a collaboration with two separate AI vendors, worth up to…