• International Progressive MS Alliance Launches Data Platform, N-Power Launches Novel Platform, More

    Clinical Research News | The International Progressive MS Alliance launched its MS Clinical and Imaging Data Resource (CIDR); N-Power Medicine announced the launch of the industry’s first Prospective External Control Arm (ProECA) platform; and more.

    Aug 26, 2025

  • Navigating the Complexities of Radiopharmaceutical Therapy Trials

    Clinical Research News | Radiopharmaceutical therapy (RPT) has been around for a long time now, but advances in technology and understanding of the actionable molecular pathways that drive cancer have fueled a resurgence in interest and investment in the therapeutic modality. he popularity of RPTs is driven largely by theranostics combining diagnostic imaging and targeted therapy into a single, integrated system to more precisely deliver radiation to tumor cells and thereby minimize damage to healthy tissue.

    Aug 21, 2025

  • Non-Invasive Medical Devices Show Clinical Promise Across Multiple Indications

    Clinical Research News | Clinical trials and preclinical studies are demonstrating the therapeutic potential of Openwater's infrared light and low-intensity focused ultrasound technologies across a diverse range of medical conditions, from cancer treatment to stroke diagnosis.

    Aug 19, 2025

  • Latin America the ‘Hidden Gem’ for First-in-Human Medical Device Trials

    Clinical Research News | The big holdup in the development of advanced medical devices seems inevitably to happen at the point where first-in-human clinical trials are to begin, at least if the studies are to be conducted in the U.S. where it can be difficult to find clinical leaders, recruit patients, and bear the overall financial burden of their execution.

    Aug 14, 2025

  • Regulatory Proposals Good Match to Priorities of New FDA

    Clinical Research News | Regardless of how one views the priorities of the Food and Drug Administration (FDA) under the new administration, it’s an opportunity for badly needed change to “shake things up,” according to Doug Bain, founder and consulting partner of UK-based ClinFlo, a newly launched consulting and service company focused on the application of technology to improve clinical research.

    Aug 13, 2025

  • How Non-Profits Are Contributing to the Clinical Research Landscape

    Clinical Research News | The clinical research landscape is undergoing a significant transformation, with nonprofit organizations emerging as pivotal players in accelerating drug development for rare diseases. In the most recent episode of the Scope of Things podcast, Annette Bakker, CEO of the Children's Tumor Foundation (CTF), shared insights into how nonprofits are revolutionizing the clinical research ecosystem.

    Aug 12, 2025

  • Five Clinical Trends Shaping the Future of TMF Strategy

    Clinical Research News | The trial master file (TMF) is the backbone of clinical trials, ensuring completeness of documentation and compliance for studies. Yet, TMF is still perceived as a file repository. Biopharma and CRO leaders are advancing their approach to make TMF a more strategic tool for study management and oversight.

    Aug 8, 2025

  • Fluorescence-Guided Surgery Shows Promise in Clinical Trials for Cancer Detection

    Clinical Research News | Researchers are making significant strides in fluorescence-guided surgery, with dozens of glowing molecular probes currently under investigation in clinical trials to help surgeons better visualize tumor margins during operations. The technology could revolutionize surgical precision and eventually enable autonomous robotic surgery.

    Aug 5, 2025

  • The Evolving Role of the Clinical Data Manager

    Clinical Research News | As gastrointestinal (GI) trials grow more sophisticated, the volume, velocity, and variety of study data have all expanded. One of the fastest-growing streams is electronic patient-reported outcomes (ePROs): diaries, symptom scores, quality-of-life surveys, and other instruments that come straight from the participant. Collecting this data quickly and conveniently is now mission critical.

    Aug 1, 2025

  • TrialX, ALS Network Partnership, Novel Multi-Cancer Detection Blood Test, More

    Clinical Research News | TrialX has joined a partnership with the ALS Network; Fred Hutch Cancer Center has launched the Vanguard Study, a national study of a new type of blood test that screens several different cancers called multi-cancer detection (MCD) tests; and more.

    Jul 31, 2025

  • Follow the Money: Platform Creates Detailed Tumor Profiles, AI Helps with Clinical Trial Benchmarking, More

    Clinical Research News | One Biosciences will further develop its OneMap platform, which creates detailed functional profiles of patient tumors that may help with optimizing clinical trials; Argon AI plans to expand their to build customized AI agents that can automate tasks, including clinical trial benchmarking; and more.

    Jul 30, 2025

  • The Connectivity Factor: How Interoperability, via AI Agents, Speeds Precision Medicine

    Clinical Research News | What if trial timelines could be cut by years—just by improving how R&D systems and ecosystems talk to each other? In a recent study using generative AI (GAI) to aid decision-making from an integrated data ecosystem, trials sped up by more than 12 months.

    Jul 25, 2025

  • AI-Powered Cell Mapping Could Transform Precision Oncology and Accelerate Clinical Trials

    Clinical Research News | Scientists at Virginia Commonwealth University (VCU) are tackling the massive computational problem of determining the distinct types of cells inhabiting biopsied tissue. Their endgame is to deploy a suite of interoperable artificial intelligence (AI) tools that can accurately and reliably guide prescribing decisions for patients with cancer as well as predict their response to investigational treatments prior to enrollment.

    Jul 22, 2025

  • How ‘Living’ Datasets Will Shape the Future of Precision Medicine

    Clinical Research News | Imagine trying to piece together a puzzle with half the pieces missing—that’s what happens when data is siloed. Without integrated, centralized data across sources, data decisions are made using incomplete, fragmented datasets.

    Jul 18, 2025

  • New Kind of Trial Tests Multiomics-Based Therapy Predictions

    Clinical Research News | As gastrointestinal (GI) trials grow more sophisticated, the volume, velocity, and variety of study data have all expanded. One of the fastest-growing streams is electronic patient-reported outcomes (ePROs): diaries, symptom scores, quality-of-life surveys, and other instruments that come straight from the participant. Collecting this data quickly and conveniently is now mission critical.

    Jul 17, 2025

  • Novel Blood Test Offers Early Cancer Treatment Response Monitoring in Clinical Trials

    Clinical Research News | A fragmentation-based blood test is providing pharmaceutical companies with a new way to monitor cancer treatment response in clinical trials, informing how drug efficacy is evaluated in early-stage development. Delfi Diagnostics has developed DELFI-TF (DELFI-tumor fraction), a research-grade assay that uses a unique fragmentation approach to detect circulating tumor DNA in blood samples.

    Jul 15, 2025

  • Smarter Starts, Stronger Trials: How Data is Driving Faster Site Activation

    Clinical Research News | Feasibility, site selection, and study startup remain some of the most time-consuming and unpredictable phases of drug development. They are also tightly interconnected, making even small delays or inefficiencies during this period especially impactful, rippling across a study’s timeline and budget and affecting site relationships and patient access.

    Jul 11, 2025

  • Scope of Things: Pragmatic Trials’ Growing Importance

    Clinical Research News | The growing importance of pragmatic clinical trials in healthcare research cannot be overstated. In the most recent episode of the Scope of Things podcast, host Deborah Borfitz speaks with Bethany Kwan, University of Colorado Anschutz Medical Campus, and Heather Smyth, Colorado School of Public Health. Together they explore the fundamental distinctions between traditional clinical trials and pragmatic research approaches, uncovering why this methodology is experiencing such significant growth in modern healthcare research.

    Jul 9, 2025

  • ICH E6(R3) Guidance: Elevating Trials through Collaboration

    Clinical Research News | After 15 years of development, Stanford University's Tom Soh is preparing to take his biosensor technology from laboratory rats to human volunteers. The device, which can continuously monitor molecules in flowing blood for up to seven days, represents a potential paradigm shift in clinical medicine.

    Jul 3, 2025

  • Stanford's Blood Flow Biosensor Heads to Human Trials

    Clinical Research News | After 15 years of development, Stanford University's Tom Soh is preparing to take his biosensor technology from laboratory rats to human volunteers. The device, which can continuously monitor molecules in flowing blood for up to seven days, represents a potential paradigm shift in clinical medicine.

    Jul 2, 2025