FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission In December 2025, the FDA finalized updated guidance on Real-World Evidence (RWE) for regulatory decision-making. It replaced the 2017 version entirely. Most product development executives have barely noticed. That’s a mistake. This isn’t a guidance refresh. It’s a […]
Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong The brutal statistics have barely budged in a decade. Eighty to 85% of clinical trials fail to meet their enrollment targets. Thirty-seven percent of investigator sites under-enroll. And 11% of sites enroll zero patients. Yet the response
In today’s rapidly evolving life sciences landscape, building an effective regulatory strategy is no longer optional—it’s essential. For sponsors navigating complex global requirements, a well-structured regulatory approach ensures smoother approvals, minimizes delays, and strengthens overall clinical trial compliance. At eteraflex connects, we understand that success in clinical trials begins long before patient enrollment—it starts with
Regulatory Strategy for Clinical Trials: A Practical Guide for Sponsors Read More »
A Strategic Framework for Accelerating Clinical Development and Maximizing ROI Global clinical trials represent one of the largest financial investments in pharmaceutical and medical device development. Yet, despite advances in science and technology, clinical trials remain operationally inefficient. A single Phase 2 or Phase 3 trial can cost over $40,000 per day, and every day
How to Reduce Delays and Costs in Global Clinical Trials Read More »
Let’s be honest: building the device is the part you love. The clinical trial? That’s usually the part that keeps you awake at night. Medical device clinical trials are unforgiving. Unlike pharmaceutical development, you aren’t just testing a molecule. You are dealing with physical prototypes, iterative software updates, and user error variables that simply don’t exist
Medical Device Clinical Trials: The Hard Truth About Balancing Speed and Compliance Read More »
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