When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory...
Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions....
Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every...
For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology.
Background A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution...
A study, published in BMJ Evidence Based Medicine, looked at caffeine use and pregnancy. At Science Media Center, Dr. Adam Jacobs, Associate Director of Biostatistics, Premier Research, said: “I note the author has published 2 books on the dangers of coffee which...