• The Scope of Things: Source Preparation Emerges as a Clinical Trial Startup Bottleneck

    Clinical Research News | Clinical trial startup delays are often attributed to budgets, contracts, and regulatory review, but a less visible bottleneck may occur at the investigative site level: source preparation. During the latest episode of The Scope of Things, Ken Getz, executive director of the Tufts Center for the Study of Drug Development, and Rick Ward, chief commercial officer at CRIO, discussed their companies’ collaboration exploring how preparing source documents delays getting the first patient in and slows enrollment.

    Sep 3, 2026

  • FDA's Real-Time Clinical Trials Initiative Takes Shape: What Near-Live Data Sharing Means for Sponsors and Operations

    Clinical Research News | The FDA's Real-Time Clinical Trials (RTCT) initiative is testing whether earlier access to selected clinical trial data can improve regulatory oversight by allowing reviewers to observe selected safety and efficacy signals while studies remain underway. Under the proof-of-concept pilot announced in April, participating sponsors share agreed-upon data elements rather than giving FDA reviewers unrestricted access to complete trial databases.

    Sep 1, 2026

  • Real-Time Clinical Trials Need a Human Exception Log

    Clinical Research News | Clinical research is getting faster. The FDA’s Operation TrialBlazer is explicitly aimed at accelerating and modernizing clinical development, while the agency has also been building toward real-time clinical trials. Faster signal flow is a meaningful advance. It can reduce the delay between what happens in a trial and what regulators or sponsors can see. But it also changes the human work around the data.

    Aug 28, 2026

  • Follow the Money: Bioanalysis Platform, Limbal Stem Cell Deficiency, Bispecific Antibody-Drug Conjugates

    Clinical Research News | Expedition Therapeutics advances its lead COPD treatment into phase 2; Ratio Therapeutics continues a clinical study of a targeted radiotherapeutic for advanced sarcomas; Abcuro prepares to launch a registration-enabling study for inclusion body myositis; and more.

    Aug 26, 2026

  • Baylor College to Open Xenoliver Transplant Center, Imperial College London, ProAxsis Collaborate, NORD Announced Three New Additions

    Clinical Research News | Owkin announced a data collaboration with Kognitic; TrialAssure’s ANONYMIZE platform has been selected by the European Medicines Agency as an official anonymization tool; The Stein Institute for Research on Aging at the University of California San Diego shall serve as the Central Laboratory and Biorepository for the XPRIZE Healthspan Competition; and more.

    Aug 25, 2026

  • MD Anderson: Immune System Provides Biological Blueprint for Treating Cancer-Related Depression with Psychedelics

    Clinical Research News | Since the brain and body are inexorably connected and seem to modulate each other, it follows that the best way to help cancer patients suffering from depression is to view the condition holistically based on their systemic and brain biology and not just their lived experience. To that end, psychedelics like ketamine and psilocybin are actively entering the treatment paradigm.

    Aug 19, 2026

  • DIOSynVax Advances Broadly Protective Vaccine Platform with Phase 1 Proof of Concept

    Clinical Research News | Digital Immune-Optimized Synthetic vaccines (DIOSynVax) is betting that the future of vaccination lies not in chasing individual viral variants, but in designing broadly protective vaccines that target entire virus families. The University of Cambridge spinout is using artificial intelligence (AI), genomics, synthetic biology, and immunology to create vaccine antigens that could be delivered through a range of existing vaccine platforms, with early clinical data supporting the concept.

    Aug 18, 2026

  • Management of Co-Occurring Conditions of Down Syndrome Becoming More Personalized

    Clinical Research News | Medical conditions vary widely in presentation, progression, and treatment response, with Down syndrome standing out as one of the most variable of all. The genetic occurrence, caused by an extra copy of chromosome 21, is widely considered one of the most heterogenous conditions, with highly variable clinical presentation from person to person.

    Aug 13, 2026

  • Blood Biomarker Panel May Enable Earlier ALS Prevention Trials

    Clinical Research News | Investigators at the University of Miami Miller School of Medicine reported that a 19-protein blood biomarker panel, which includes neurofilament light chain (NfL), accurately predicted the transition from presymptomatic disease to clinical amyotrophic lateral sclerosis (ALS), known as phenoconversion, across timeframes ranging from six months to five years.

    Aug 12, 2026

  • Primary Care Research Alliance ‘Flips the Script’ on Site Feasibility

    Clinical Research News | In the U.K., adversity has brought together 180 clinical trial sites—mostly GP (general practitioner) practices but also community health trusts, hospices, and home care providers—to realize that they have more to gain as collaborators than competitors. The mindset shift prompted the formation of the Primary Care Research Alliance (PCRA), which in the space of 18 months has grown from a core group of 12 practices with 250,000 patients to a network representing 8.5 million and counting.

    Aug 11, 2026

  • The Scope of Things: Chinese Drug Developers Look Toward Global Market

    Clinical Research News | In the most recent episode of The Scope of Things podcast, Daphne Smyth, head of global regulatory programs at Veristat, joins the conversation to relay her three days at BioChina 2026 in Suzhou and what the North American and European markets can expect from Chinese drug development.

    Aug 6, 2026

  • Vaccine ‘Intercepts’ Pancreatic Cancer in High-Risk Populations

    Clinical Research News | Fresenius expands its access to innovation networks through its own corporate venture capital fund; Draig accelerates pipeline of highly specific AMPA and GABAA receptor modulators; and more.

    Aug 4, 2026

  • Fresh Insights on What Helps Patient Recovery in the ICU

    Clinical Research News | The findings of more than 150 randomized controlled trials provide ample evidence that early mobilization of patients with acute respiratory failure (ARF) in the intensive care unit (ICU) is both safe and beneficial. Surprisingly, also giving them extra protein—a strategy used successfully with frail and elderly patients—doesn’t appear to have any additive benefit.

    Jul 30, 2026

  • Follow the Money: Metastatic Prostate Cancer, Once-Weekly GLP-1 Patch, Molecule Arts Platform

    Clinical Research News | Fresenius expands its access to innovation networks through its own corporate venture capital fund; Draig accelerates pipeline of highly specific AMPA and GABAA receptor modulators; and more.

    Jul 29, 2026

  • Flatiron Health UK, NHS Greater Glasgow and Clyde New Partnership, Acrosian’s Next-Gen Biometrics CRO, Spatial Biology in Clinical Research

    Clinical Research News | Parhelia Biosciences and Sirona Dx announce a strategic partnership; The University of Cincinnati and UC Health launched the Center for Alzheimer's and Neurodegenerative Diseases Research; and more.

    Jul 28, 2026

  • Now Enrolling: Massive Remote Study Tracking How the Brain Ages

    Clinical Research News | In the future, it may be possible for the physiological signals passively collected by a smartwatch to alert the wearer of a potential change in their cognitive state. Consumer electronics giant Samsung, for its part, has teamed up with the Neuroscape Center at the University of California San Francisco (UCSF) to explore the possibility of expanding the health- and fitness-tracking capabilities of its Galaxy Watch to assess functioning of the brain.

    Jul 23, 2026

  • Anthropic Announces Rare Disease Research Claude Grants

    Clinical Research News | Anthropic yesterday announced a focused call for applications for work on rare genetic diseases. Accepted applicants will receive up to $50,000 in Claude credits over six months, with the goal of building a community of researchers looking into how AI can reshape our understanding of rare disease.

    Jul 21, 2026

  • 3 Tips for a Lean and Efficient Clinical Data Management Function

    Clinical Research News | The landscape of clinical data management (CDM) is becoming increasingly complex. As a BCG report notes, sponsors’ expectations are rising. They are looking for greater consistency in speed and quality, better technology, and improved implementations.

    Jul 17, 2026

  • Coming Soon: One-time Treatment for Debilitating Genetic Condition

    Clinical Research News | Patients with hereditary angioedema have reason to be optimistic that regulatory approval of a one-time, in vivo CRISPR gene-editing therapy for the sudden and severe swelling attacks associated with the rare genetic condition could come as early as next year. Lonvoguran ziclumeran (lonvo-z), as it is known, has been under development by Intellia Therapeutics for the past six years.

    Jul 15, 2026

  • AI Eye Imaging Model Could Accelerate Clinical Trials and Drug Development

    Clinical Research News | An experimental artificial intelligence (AI) model called OCTCube-M could help improve patient selection, predict disease progression, and streamline clinical trials by extracting new insights from three-dimensional optical coherence tomography (OCT) eye scans.

    Jul 14, 2026