AI Is Now Running Clinical Trials. The Question Is Whether Anyone Is Watching.
From a cancer patient's self-built AI agent to ARPA-H's phaseless trial model, AI has crossed from analytics into operations....
Decentralized Clinical Trials
The Eye as a Biomarker: Why Retinal AI Could Reshape How Trials Screen and Stratify Pregnant Patients
A Nature Biotechnology retinal AI model detects preeclampsia and gestational hypertension risk non-invasively, and its trial implications go far...
Scaling Clinical AI to One Million Patients Taught Us Things No Pilot Study Could
A Nature Medicine analysis of 1M+ patient AI deployments across three healthcare systems reveals the infrastructure gaps sponsors must...
Lecanemab’s At-Home Start Dose Just Rewrote the Rules for Alzheimer’s Trial Design
FDA's July 2026 approval of at-home subcutaneous lecanemab initiation eliminates the 18-month IV requirement, reshaping CNS trial recruitment and...
When Your CRO Gets Acquired, Your Site Activation Timeline Pays the Price
Curavit's acquisition of Lindus Health CRO assets combines 1,000+ global sites with DCT infrastructure—but site teams absorb the operational...
CMS Just Declared War on RPM Vendors. Clinical Trial Sponsors Should Be Paying Attention.
CMS's proposed 2027 fee schedule would ban Medicare payments for third-party RPM vendors after OIG flagged $536M in billing...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
EU Clinical Trials Face Cost, Speed, and China Competition Pressure
At the Clinical Trial Innovation Summit 2025 in Basel, industry leaders from UCB, Novo Nordisk, Novartis, and Medable debated...
Novartis Restructures Clinical Ops to Scale Trial Innovation Beyond Pilots
Novartis built a dedicated Global Clinical Operations Innovation Team 18 months ago to move past one-off pilots and embed...