Real-World Data / Real-Word Evidence Insights

71. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

72. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

73. Developing A Risk-Based Model For Computer System Validation 9/11/2025

    Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.

74. 3 FDA Guidance Documents That Shaped Today's Computer System Validation 9/10/2025

    Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.

75. Synthetic Control Arms: When Data Stands In For Patients 8/14/2025

    Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

76. Is Double Programming Really Required For Validation? 3/10/2025

    Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.

77. Meaningful Industry Change Means Balancing Tech And Human Touch 5/6/2024

    Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.

78. Embracing Hybrid Trial Design — How, When, & Why To Use It 6/28/2023

    Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.

79. Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities 6/23/2023

    One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.

80. Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner 6/19/2023

    Today, we have access to more data than ever before, and in an ever-advancing technological landscape, it is increasingly important to adopt a safety-centric monitoring approach that ensures we can measure safety data in real time and in a standardized manner across the industry. The challenge now is how to extract and leverage the quality data from the large volume that we have access to.