Category: Blog

  • 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…

  • CRO Outsourcing in Clinical Trials: Key Considerations for Sponsors

    CRO Outsourcing in Clinical Trials: Key Considerations for Sponsors

    CRO outsourcing is common practice in clinical trials; as the global clinical research market becomes ever more competitive, small to mid-size pharmaceutical and biotech companies must rely on the expertise, services and facilities of specialist clinical research organisations (CROs) and functional service providers (FSPs) to support their clinical development programs. By outsourcing to CROs with…

  • Common challenges in bioanalytical method development

    Common challenges in bioanalytical method development

    The development of bioanalytical methods and subsequent quantification of analytes in a range of biological matrices is fundamental to the drug discovery and development process. Having a reliable and robust methodology, for all target species, including human, plays a key role in understanding how investigational drugs are metabolised following administration.  By accurately evaluating both the…

  • Clinical Considerations for First-in-Human (FIH) and Early Phase Clinical Trials

    Clinical Considerations for First-in-Human (FIH) and Early Phase Clinical Trials

    You are coming close to having completed your nonclinical studies and you are beginning to think about your next steps.  But exactly what are those?  Chances are you are moving into unknown territory with your asset, and you may even have a crucial milestone to consider.  How do you navigate your way through the regulatory…

  • Project Management for Clinical Trials

    Project Management for Clinical Trials

    The world of medical research and development is constantly advancing, and clinical trials play a crucial role in bringing new treatments and cures to patients. However, conducting a successful clinical trial is a complex and expensive undertaking with the average cost of bringing a drug to market being around $2.3B. Clinical trials require precise planning,…

  • Nonclinical development strategies to optimise your clinical development programme

    Nonclinical development strategies to optimise your clinical development programme

    Being first to market with an innovator drug remains the ultimate goal for all, and most organisations are constantly reviewing timelines in order to achieve efficiencies through trial design, conduct and the reduction of downtime between phases of drug development. But clinical trials and drug development is an expensive and slow process, representing approximately 60%…

  • Patient recruitment strategies for rare disease trials

    Patient recruitment strategies for rare disease trials

    One of the key challenges facing researchers working on treatments for rare diseases is recruitment for clinical trials. Because these diseases are relatively uncommon, it can be difficult to find enough patients to participate in studies and help advance treatment options. Additionally, there is often a lack of awareness for the condition, making it difficult…

  • The 4 Types of clinical trial monitoring

    The 4 Types of clinical trial monitoring

    In recent decades, clinical trials and their methodologies have evolved significantly. New technologies have led to improved research methods, techniques and strategies in clinical trial management and in site management and monitoring specifically. Additionally, new regulations and other external factors have resulted in changes to clinical trial approaches. For instance, social distancing restrictions during the…