Managing Food Effect Studies in Modern Bioequivalence Programs
For many orally administered drug products, what happens after a patient takes a dose can depend heavily on whether they have recently eaten a meal. Food can alter how a drug is absorbed, how quickly it reaches circulation, and ultimately how it performs in the body. Understanding these effects is a critical component of drug […]
Phase I/TQT Cardiac Assessment Expedited Solutions
How CRO Infrastructure Impacts Inspection Outcomes
When sponsors evaluate a contract research organization (CRO), discussions often focus on timelines, enrollment capabilities, therapeutic expertise, and cost. While these factors are important, there is another consideration that can have a lasting impact on study success: infrastructure. A CRO’s infrastructure extends far beyond its physical facilities. It encompasses the systems, processes, technology, personnel, quality […]
The Role of Centralized Monitoring in Early Phase Risk Management
By: Dr. Michelle Radke (AXIS – Medical Principal Investigator) Early phase studies move fast, and the margin for error is thin. A single ascending dose cohort can generate safety data such as clinical labs, vital signs, ECGs, and adverse events, along with PK samples, all of which must be reviewed, reconciled, and acted on before […]
Managing Food Effect Studies in Modern Bioequivalence Programs
For many orally administered drug products, what happens after a patient takes a dose can depend heavily on whether they have recently eaten a meal. Food can alter how a drug is absorbed, how quickly it reaches circulation, and ultimately how it performs in the body. Understanding these effects is a critical component of drug […]
When Adaptive Design Works (And When It Doesn’t): A Sponsor’s Early Phase Decision Guide
Early phase development has always demanded speed and rigor-sometimes in tension. Today, sponsors face a new pressure: the complexity of molecules and the crowded competitive landscape mean that a 12-month Phase I no longer feels optional; it feels like a competitive disadvantage. Adaptive designs are reshaping how we approach this tradeoff. In their place, adaptive […]
Honoring International Clinical Trials Day
Clinical research has transformed modern medicine in ways that were once unimaginable. From vaccines and cancer therapies to biosimilars and precision medicine, nearly every major advancement in healthcare can be traced back to the patients, investigators, clinicians, and research professionals who made clinical trials possible. The world of clinical research goes back to around the […]