Your IP Is Sitting in a Freezer Somewhere, And Your CRA Doesn’t Know Where
Decentralized supply management is breaking traditional cold-chain oversight. Here's what DSM failures cost sites in enrollment ramp and budget...
Clinical Trial Ops Brief
Enrollment Closed: What Moleculin’s MIRACLE Trial Teaches About AML Site Execution
Moleculin closed Part A enrollment at 89 subjects in its pivotal AML MIRACLE trial. Here's what site directors and...
Fortrea’s $45M Phase I Grab Is Your Vendor Continuity Problem Now
Fortrea's $45M acquisition of Worldwide Clinical Trials' early-phase division reshapes Phase I site networks and vendor contracts for sponsors...
Fortrea’s $45M Early Phase Deal Sets a 90-Day Test for Sponsors With Active Studies
Fortrea's $45M buy of Worldwide Clinical Trials' Early Phase Services unit means active sponsors face contract novation, lab method...
When Your CRO’s AI Sends a Query, Who’s Accountable for the Answer?
ICON's Anthropic partnership deploys Claude into clinical trial monitoring. Here's what site coordinators and ops leads need to verify...
What ICON’s Claude Deal Actually Means for the Site Coordinator Running Your Trial
ICON's Anthropic partnership deploys Claude AI into clinical trials. Here's what it means for EDC workflows, IRB docs, and...
The Genetics Are Global. Your Enrollment Plan Isn’t.
A landmark Lancet Neurology study exposes the operational gap in Parkinson's trials: ancestry-based biomarker screening built for European cohorts...
The Genetic Trial Diversity Problem Is Now a Site Operations Problem
A 99,783-person multi-ancestry Parkinson's study just exposed a critical enrollment gap: GBA1 and LRRK2 trials run almost exclusively in...
When the Phase 3 Dies After the Acquisition: The Site-Level Fallout No One Plans For
GSK's Phase 3 termination of camlipixant after its $2B Bellus Health buyout triggers an operational cascade—site deactivation, IRB amendments,...
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Your Recruitment Plan Is Failing Before Screening Even Starts
59% of sites report recruitment blocked by process inefficiencies—the bottleneck isn't patient supply, it's the workflow that never gets...