How Early-Stage Intelligence Determines Late-Stage Success
Why competitive insight in the earliest stages of developing a therapy can determine ultimate success By Alex Angelopoulos, Life...
How Early-Stage Intelligence Determines Late-Stage Success
Why competitive insight in the earliest stages of developing a therapy can determine ultimate success By Alex Angelopoulos, Life...
The Seven-Day Miracle: Why the FDA’s New Pathway Could be the End of Randomized Clinical Trials
The parents of Baby K.J. (Kyle Patrick Muldoon, Jr.) didn’t have years to wait for a double-blind, placebo-controlled trial....
Data Gluttony? Why Big Pharma is Addicted to 5.9 Million Useless Clinical Trial Datapoints
The lead site coordinator stared at the tablet, then at the patient, then back at the tablet. They were...
Why Correcting Trial Imaging Errors at Central Review Is Too Late—and Too Expensive
The patient drove two hours each way for the trial, which her oncologist and she believed was her best...
FDA’s National Priority Voucher Program Is Just a Modular PMA Rebrand, With Risks
In June 2025, FDA announced its new Commissioner’s National Priority Voucher (CNPV) program, a headline-grabbing reform that promises to...
ICH E6(R3) Raises the Bar on Imaging in Clinical Trials—Are You Ready?
When the FDA inspector arrived, no one expected imaging to be the issue. The scans had been read. The...
FDA and EMA Push for Predicting Protocol Deviations. How Psychology Can Help
The site team was blindsided. The patient met every inclusion and exclusion criterion, showed no red flags, and even...
Guidance Documents Do Not Favor Big Pharma
In 2025, a surge of FDA guidance updates signaled a broader shift in the clinical trial ecosystem. They marked...
Behavioral Science: The Untapped Asset in Obesity Trial Strategy
The global obesity epidemic has shifted from a public health issue to a fiercely competitive pharmaceutical frontier. With GLP-1...