Expert Insights On Data Management & Analysis

71. Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency 7/17/2023

    The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?

72. No More XPT? Piloting New Dataset-JSON For FDA Submissions 7/12/2023

    CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.

73. Key Takeaways From The EU MDR Expert Panels' First Published Scientific Opinions 7/10/2023

    The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panels' first published scientific opinions.

74. Shared Knowledge & Shared Data Is Crucial To Developing Innovative Therapies For SCIs 7/7/2023

    In this Q&A, Chief Science Officer Marco Baptista, Ph.D., discusses the Christopher & Dana Reeve Foundation's focus on and approach to data and knowledge sharing, as well as patient engagement, as it works to advocate for and fund the development of spinal cord injury (SCI) therapeutics.

75. 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.

76. 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.

77. BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity 6/15/2023

    On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.

78. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

79. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

80. Tapping Into AI/ML Partnerships To Advance Drug Discovery With Recursion Pharma 6/8/2023

    "TechBio" company Recursion Pharma has entered agreements to acquire AI/ML company Cyclica for $40 million and Valence for $47.5 million. To learn about the acquisitions and the future of AI/ML in drug discovery and development, we caught up with Recursion’s CEO Chris Gibson.