What Icon’s $300M Microsoft Bet Means for the Sites Running Their Trials
Icon's enterprise-wide Microsoft Copilot deployment and $300M AI investment will reshape how CRAs monitor, query, and escalate — here's...
When Your CRO’s AI Platform Upgrades, Who Pays for the Change Management?
Icon's Microsoft-Copilot partnership scales its Orbis AI platform enterprise-wide. For sites and sponsors mid-trial, the operational cost question starts...
When Your Sponsor Gets Acquired Mid-Trial, Your Site Pays the Operational Price
Lilly's $7.8B Centessa acquisition closes June 24—here's what site coordinators and ops leads must do before the IND transfers...
The FDA’s Bayesian Guidance Arrives at Your Site Whether You’re Ready or Not
FDA's January 2026 Bayesian statistics draft guidance reshapes protocol design, interim analysis workflows, and site staffing budgets—here's what operators…
When the Protocol Keeps Changing: What MAMS Trials Actually Cost Sites to Run
The OCTOPUS progressive MS platform trial has enrolled 700+ participants across dynamic arms. Here's what sites need to know...
The FDA’s Bayesian Guidance Sounds Like Good News for Sponsors. Sites Will Feel It Differently.
FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
Lilly’s Bet on Abridge Exposes the Recruitment Handoff Nobody Wants to Own
Eli Lilly invested in Abridge's AI recruitment tool — but the real question is whether sites can operationalize patient...
The Single Phase 3 Default Is Already Changing How Sites Get Activated — Are You Ready?
FDA's February 2026 single-trial default standard is compressing enrollment timelines and reshaping site contracts. Here's what ops teams must...
When Your CRO Gets Acquired Mid-Trial, the Site Pays the Operational Price
Tevogen Bio's MSO/CRO acquisition push signals a consolidation wave that will disrupt site activation, monitoring, and contracts mid-study. Here's...
When the Manufacturing Site Fails, Your Enrollment Plan Fails With It
Novo Nordisk's Bloomington facility hit with another FDA 483 — here's how manufacturing findings cascade into site enrollment holds,...