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What Really Happens At The Site When Sponsors Pull Back Mid-Trial
18+ hour, 20+ min ago (436+ words) Guest Column | June 19, 2026 By Amy Ford, CCO, Curo Research In clinical research, there is an assumption that once a trial is underway, the operational engine will continue running with relative stability. Timelines may shift and enrollment may fluctuate, but the…...
Where Are We With Clinical Trial Tokenization?
18+ hour, 21+ min ago (161+ words) From The Editor | June 19, 2026 By Dan Schell, Chief Editor, Clinical Leader Back in January 2024, I interviewed Tom Dougherty about a topic many clinical research professionals had heard mentioned but few could confidently explain: tokenization. More than two years later, that…...
Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
2+ day, 18+ hour ago (83+ words) Guest Column | June 17, 2026 By H. Greg Thomas, Ph. D. , vice president of R&D, Kiel Laboratories In early 2026, the FDA further strengthened its rare disease regulatory infrastructure. The current regulatory landscape for orphan drugs emphasizes the FDA's push toward more flexible pathways…...
One Drug, Three Indications: How Small Clin Ops Teams Manage Multi-Trial Execution
2+ day, 18+ hour ago (301+ words) Guest Column | June 17, 2026 By Maureen Higgins, Ph. D. , MBA, vice president, head of clinical operations, Step Pharma That is certainly true for our team at Step Pharma. Our clinical operations group consists of three people. In a small biotech, the success…...
AI In Clinical Trials: Why Process Orchestration Matters More Than The Model
3+ day, 8+ hour ago (174+ words) Clinical Leader Article | June 16, 2026 AI In Clinical Trials: Why Process Orchestration Matters More Than The Model By Abraham Gutman, Founder & CEO, AG Mednet AI is rapidly becoming a larger part of clinical trial operations, powering tasks such as data review,…...
The Compliance Problem With Excel Trackers And Other Computational Tools " And How AI Can Help
3+ day, 18+ hour ago (742+ words) Clinical Leader Guest Column | June 16, 2026 The Compliance Problem With Excel Trackers And Other Computational Tools " And How AI Can Help By Sidharth Ananthanarayan, clinical research and quality professional Word, Excel, Power Point, Outlook, Gmail, and other everyday tools have become…...
To Prevent Parkinson's Disease, We Need New Biomarkers
3+ day, 18+ hour ago (1023+ words) Guest Column | June 16, 2026 By Andrea Pfeifer, cofounder and CEO, AC Immune The approval of the first disease-modifying treatments for Alzheimer's disease (AD) marked a significant landmark in transforming the way we address neurodegeneration. Can this progress in AD be extended…...
How Remote Pharmacy Monitoring Strengthens Compliance and Streamlines Clinical Trial Operations
4+ day, 6+ hour ago (185+ words) Clinical Leader How Remote Pharmacy Monitoring Strengthens Compliance and Streamlines Clinical Trial Operations By Rachael Aletti, Pharm. D. Remote monitoring has become a transformative practice for Investigational Drug Services (IDS) pharmacies, enabling more efficient oversight of investigational product (IP) accountability while…...
Why Clinical Data Standards Matter In An AI-Driven World
1+ week, 1+ day ago (483+ words) Guest Column | June 11, 2026 By Bill Illis, Novartis Hardly a day passes without a new headline claiming AI will transform every step of drug development. Many of these highly publicized claims come from pilot studies, small-scale implementations, or isolated point solutions....
How The Quiet Data Standards Revolution Is Impacting Drug Approval
1+ week, 1+ day ago (688+ words) Clinical Leader Guest Column | June 11, 2026 How The Quiet Data Standards Revolution Is Impacting Drug Approval By Varun Debbeti, principal statistical programmer When a patient hears that a drug was just approved by the FDA, they picture scientists in labs, clinical…...