Insights On Trial Design

  1. Clinical Services Company Eliminates Drug Supply Waste

    How the use of tools can enable your objective of ensuring patient safety by having the right amount of material available with an appropriate investment in inventory cost.

  2. The Treacherous Study Startup Journey

    With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start.

  3. Disassembling Endemic Silos In Pharma Pivotal To Improving The Clinical Trial Continuum

    Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.

  4. Proactive Planning Is Key To Process And Quality Improvements In Clinical Trials

    How to employ processes that take an upfront approach to preventing or mitigating problems associated with document completion.

  5. Gene Expression For Keeping Pace With Immuno-Oncology Breakthroughs And Biomarker Identification

    A summary of the clinical relevance of RNA-Seq as well as when and how to use gene expression profiling for biomarker discovery for immunotherapy trials.

  6. Pediatric Clinical Trials: The Need for Regulation

    An overview of the progress that has been made in pediatric drug development.

  7. Orphan Indications and Clinical Trials - Recruiting

    Look at ways to proactively recruit so as to overcome challenges.

  8. Orphan Indications and Clinical Trials - Why Rare Diseases Warrant Special Treatment

    Unique characteristics of clinical trials for chronic, rare diseases.

  9. Cellular Therapy Studies: 7 Common Challenges

    Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.

  10. Five Key Considerations For Writing First-In-Human Protocols Under EMA Guidelines

    As pharmaceuticals move from animal to first-in-human (FIH) clinical trials, establishing appropriate strategies to minimise risk in early phase clinical trials is necessary and should be a priority for the safety and wellness of clinical trial participants, whether patients or healthy volunteers. The goal of FIH clinical trials is to study the human pharmacology, tolerability and safety of pharmaceuticals to compare how effects seen in non-clinical studies translate into humans.