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...
Site Operations
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FDA's January 2026 Bayesian statistics draft guidance reshapes protocol design, interim analysis workflows, and site staffing budgets—here's what operators…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FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
The Coordinator Crunch Is Costing You Patients — Not Just Morale
Coordinator burnout drives enrollment collapse. Here's the operational math sponsors miss—and what sites need from Monday morning.
The eCOA Vendor Stack You Built Is Already Obsolete
Signant Health's acquisition of Ametris on May 14 consolidates eCOA and wearable data streams—and exposes the real cost of...
When the Sponsor’s Name Changes Mid-Trial, Sites Pay the Operational Price
BioMarin's $4.8B Amicus acquisition closed April 27—now sites running Amicus trials face contract ownership gaps, monitoring voids, and enrollment...