• Checking the Boxes for Expanding Trial Start-ups to New Countries

    Clinical Research News | The patient-centered approach that has come into favor for planning and conducting clinical trials is, without question, improving care for trial participants. However, combined with other industry trends, including the proliferation of rare disease studies with much smaller patient pools, it is causing trial protocols to become more complex and is creating challenges in patient recruitment, which can lead to costly delays in a competitive and challenging macroeconomic environment.

    Nov 21, 2025

  • Early Rheumatoid Arthritis Studies Redefine Prevention and Clinical Research

    Clinical Research News | Rheumatoid arthritis has a reputation as a lifelong condition with no real cure and can only be managed after symptoms appear. However, researchers from the Allen Institute for Immunology, University of California, San Diego, and the University of Colorado Anschutz, have mapped out a way to detect dramatic immune system changes before the joints start swelling.

    Nov 19, 2025

  • Pioneering Platform for Collecting ‘Home-Reported Outcomes’

    Clinical Research News | As anyone contending with a complex chronic disease can likely attest, a lot has been “left on the table” when it comes to opportunities to achieve better health outcomes, lower costs, and greater personal satisfaction with their medical care. Tens of thousands of patients have voted for change by registering for the Folia Health app, which allows them to track their symptoms and share data about their own healthcare experiences with their care team or research studies.

    Nov 18, 2025

  • Making Sense of Sex in Clinical Trials

    Clinical Research News | Roughly two-thirds of pivotal clinical trials leading to a drug approval by the U.S. Food and Drug Administration (FDA) now include women at rates either at or above the disease burden on the female population. Yet progress on their inclusion has “plateaued” since the FDA began releasing its Drug Trials Snapshots in 2015 because of “fundamental issues in not considering female biology."

    Nov 12, 2025

  • Less Can Be More When It Comes to Collecting Data in Studies

    Clinical Research News | It is no secret that clinical trial protocols have grown increasingly complex, resulting in longer study durations, higher costs, and greater burden on patients and investigative sites. It has been a consistent, well-documented trend for more than two decades now.

    Nov 11, 2025

  • Next-Gen Weight-Loss Drug Moves Closer to Clinical Trials

    Clinical Research News | Developing a “super-tolerable” weight loss drug is one of the biggest challenges in obesity medicine today. Researchers recently reported the creation of a promising molecule, tridecaneuropeptide (TDN), which reduces food intake without triggering the awful side effects often associated with glucagon-like peptide-1 (GLP-1) drugs such as Ozempic and Zepbound.

    Nov 6, 2025

  • Site Payments: Transparency, Timeliness, and Trust

    Clinical Research News | For all the technological advances in clinical research, one issue remains stubbornly unresolved: timely, transparent payments to sites. At the latest SCOPE 365 ClinEco Connect, industry peers came together to examine why, after decades of discussion, site payment challenges persist, and what practical steps could finally close the gap.

    Nov 5, 2025

  • AI in Clinical Trials: Industry Leaders Discuss Implementation Challenges and Future Directions

    Clinical Research News | At SCOPE Europe, Allison Proffitt hosted a panel of pharmaceutical industry leaders to discuss the real-world implementation of artificial intelligence in clinical trials, moving beyond theoretical benefits to address practical challenges and measurable outcomes.

    Nov 4, 2025

  • Pangaea, Microsoft Collaboration, First-in-Class Monoclonal Antibody for Cancer, New LLM Tech

    Clinical Research News | Pangaea Data announces a collaboration with Microsoft; Ipsen acquires ImCheck Therapeutics; Flatiron Health released first-of-their-kind advances in LLM-extracted progression data and other uses; and more.

    Oct 29, 2025

  • Follow the Money: Best-in-Class Weight Loss Drug Trial, Novel eClinical Platform, Rheumatoid Arthritis, Other Diseases Treatments

    Clinical Research News | Kailera Therapeutics advances injectable dual GLP-1/GIP receptor agonist; Almac Group plans Almac Trial Coordinator, a first-in-class interoperable clinical trial technology platform; Elvara advances their upcoming phase 2 clinical trial of its lead candidate ELV001; and more.

    Oct 28, 2025

  • GenAI Agents and Regulatory Compliance: Streamlining Unstructured Data Extraction Gets a Lift from GenAI Agentic Frameworks

    Clinical Research News | Imagine that you’re a life sciences researcher tasked with answering a regulatory request that involves extracting meaningful data from over 200 clinical trial reports from various sources. You’re looking for patient demographics, study outcomes, adverse events, and dosage information. For decades, the industry has relied on manual effort, but GenAI agents enable far better unstructured data extraction.

    Oct 24, 2025

  • Europe's Clinical Trial Crisis: Industry Leaders Call for Urgent Action at SCOPE Europe

    Clinical Research News | European clinical research is at a critical crossroads, industry leaders warned last week at SCOPE Europe. Regulatory fragmentation, site readiness challenges, and prolonged approval timelines are driving sponsors to more competitive markets in Asia and the United States.

    Oct 22, 2025

  • ‘Simple’ NLP Tool Streamlines Metastatic Cancer Research

    Clinical Research News | Researchers at the Medical University of South Carolina (MUSC) are using a “super-simple” natural language processing (NLP) tool to streamline clinical research for metastatic brain cancer, a field where rapid advances in therapy are outpacing traditional methods of data analysis.

    Oct 21, 2025

  • The Scope of Things: Tackling the Deadlocks in Patient Recruitment

    Clinical Research News | Clinical trial recruitment has long been a hurdle in medical research, and despite decades of discussion, the obstacles are still standing, particularly in adapting marketing strategies to today’s digital world. On the latest episode of The Scope of Things, host Deborah Borfitz spoke with Christine Senn, senior vice president of site sponsor innovation at Advarra, about the challenges sites and sponsors face and offered some practical tactics for solving them.

    Oct 17, 2025

  • Anju, Clinical Trials Information Network Win Best of Show at SCOPE Europe 2025

    Bio-IT World | The SCOPE Europe 2025 Best of Show winners have been announced! This year, 22 finalists presented their products in the exhibit hall, and attendees voted for the most innovative and impactful technologies, tools, products, and solutions used by life sciences.

    Oct 16, 2025

  • SCOPE Europe 2025 Best of Show Entries

    Clinical Research News | It’s time to vote for the SCOPE Europe 2025 Best of Show awards! This year, there are 22 finalists that will be displaying their products in Barcelona. Attendees of SCOPE Europe are invited and encouraged to identify extraordinary innovative technologies used by life science professionals and to vote on the most impactful new products of the year.

    Oct 10, 2025

  • Out-of-the-Box CRA First ‘Agentic Teammate’ to Join Study Teams

    Clinical Research News | Clinical research associates (CRAs) may soon be working alongside an artificial intelligence (AI) agent offering relief from some of the drudgery of the job, including crunching data from a dozen or more data sources in search of meaningful insights and actionable information. Medable has just launched Agent Studio, the first agentic AI platform purpose-built for life sciences that comes with an out-of-the-box CRA agent.

    Oct 8, 2025

  • Unlocking New Pathways for Treating Recurrent Ovarian Cancer

    Clinical Research News | Recurrent ovarian cancer treatment has always had dismal responses because differences between cancer patients are not fully understood. To tackle this challenge, a team from the Department of Oncology of the Lausanne University Hospital and the Lausanne, Switzerland branch of the Ludwig Institute for Cancer Research conducted a large-scale clinical research study to provide insight into how immune and genomic signatures may finally guide more effective care.

    Oct 7, 2025

  • Clinical Trials Drive Innovation in Infant Gut Health

    Clinical Research News | In a food system that prioritizes profits and quantity over nutritional quality, most babies born today lack the gut microbes they need before kindergarten to train their immune system. Persephone Biome, a California-based biotech company, is tackling this issue with its latest product, the Daily Synergistic Synbiotic.

    Oct 2, 2025

  • Combining eCOA and Objective Digital Endpoints: Promise and Pitfalls

    Clinical Research News | The clinical research industry is awash in new data streams. With the rise of wearables, sensors, and smartphone-based assessments, objective digital measures are increasingly complementing traditional patient-reported outcomes. But should these endpoints be combined, or is it better to keep them separate? A recent SCOPE 365 ClinEco Connect session brought together experts and industry participants to wrestle with this question.

    Sep 30, 2025