Change is inevitable—but successful change is an art. As a seasoned change agent, I’ve led numerous initiatives, from Quality Management System overhauls to M&A integrations. I’ve studied the theories, applied the models, and navigated the...
Read MoreInvesting in Women’s health benefits ALL of us For decades, medical research has disproportionately focused on men, leaving critical gaps in our understanding of women’s health. But when we invest in studying conditions that primarily...
Read MoreAh, summer—the season of sunshine, vacations, and… compliance headaches? That’s right! While you’re dreaming of beach days and ice-cold lemonade, the medical device and pharmaceutical industries are sweating over temperature spikes, staffing shortages, and supply...
Read MoreIt happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
Read MoreAn Unpopular Opinion The recent court decision in American Clinical Laboratory Association (ACLA) v. FDA struck down the FDA’s rule regulating laboratory-developed tests (LDTs), ruling the agency lacked statutory authority. While the court was legally...
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