• AI Platform Could Aid Precision Dosing for Multiple Conditions

    May 13 | Clinical Research News | Given information on two blood biomarkers, together with drug type and dose, artificial intelligence (AI) was used to create personalized “digital twins” of cancer patients in an interventional clinical trial at a pair of Singapore hospitals. The goal was to “optimize only their own doses, dynamically." More

  • The Path To TMF Inspection-Readiness

    May 09 | Clinical Research News | Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection. More

  • ALS Research Getting a Big Boost from Open Science Initiative

    May 08 | Clinical Research News | A diagnosis of amyotrophic lateral sclerosis (ALS) is devastating news given to about 5,000 people in the U.S. each year. It is a rare central nervous system disease without a cure that relentlessly progresses, although death variably occurs anywhere from a few months to many years after symptoms first become noticeable. More

  • Joan Chambers on the Impact of Decentralized Clinical Trials

    May 06 | Clinical Research News | At last month’s Bio-IT World Conference & Expo, Joan Chambers, Senior Consultant at Tufts Center for the Study of Drug Development (CDSS), spoke extensively about the future of clinical trials, particularly on the impact of decentralized clinical trials (DCTs), approaches that improve accessibility and convenience for the trial process, and insights on solutions for patient recruitment and retention. More

  • Mayo Clinic New Research, BioProcess360’s New Biotech Company, Flatiron Health, Massive Bio Partnership, More

    Apr 30 | Clinical Research News | FYR announced a collaboration with Mayo Clinic seeking to advance the use of blood-based biomarkers in Parkinson’s disease research and clinical applications; BioProcess360 Partners announced the formation of ChromaGenix, a new biotechnology company focused on advancing downstream purification technologies for emerging biotherapeutics; Flatiron Health announced a strategic partnership with Massive Bio to expand patient identification capabilities and improve clinical trial enrollment across the US; and more. More

  • Follow the Money: AIRNA’s RNA Editor, Rare Disease Trial, More

    Apr 29 | Clinical Research News | AIRNA will further develop its AIR-001 to address AATD by targeting and repairing the SERPINA1 mutation in the RNA transcript; Glycomine will advance its lead candidate, GLM101, into a Phase 2b clinical trial for a rare and life-threatening genetic disorder with no approved treatments; and more. More

  • Patient-Focused Clinical Trial Design Using Net Treatment Benefit

    Apr 25 | Clinical Research News | Pharmaceutical companies and regulators are increasingly aligning around the need to better incorporate patient preferences into clinical trial design. This shift stems from a broader movement to measure whether treatments are efficacious on terms that are also valuable from the patient’s perspective. More

  • Rethinking the Role of Nonprofits in the R&D Ecosystem

    Apr 24 | Clinical Research News | Pharma companies and academic institutions are key players in drug development but operate in disconnected ecosystems. Universities are constantly developing highly innovative drug screening models, while industry has many promising molecules and drug compounds, yet the two worlds more often collide than collaborate to get needed medicines to patients faster. More

  • New Research Identifies Superior Biomarker for Stroke and Dementia Risk

    Apr 23 | Clinical Research News | Researchers have identified "left atrial reservoir strain" as the best biomarker for predicting stroke and dementia risk, according to a new study published in the journal Stroke. The research, led by Dr. Lin Yee Chen of the University of Minnesota Medical School, compared various methods of detecting left atrial (LA) myopathy, an abnormality of the heart's left atrium that can indicate elevated risk even without atrial fibrillation (AFib). More

  • Precursors to Empowering QARA Professionals with AI-Driven Technologies

    Apr 18 | Clinical Research News | As life sciences companies increasingly embrace artificial intelligence and digital transformation, quality assurance and regulatory affairs professionals face opportunities and challenges. The journey from paper-based systems to AI-driven solutions requires careful consideration of the various factors required to ensure successful implementation while maintaining global compliance and product quality to ensure the provision of safe and effective patient solutions and treatments. More
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SOT

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

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