“This is a pivotal moment in women’s health as unmet needs continue to grow. The women’s health market is expected to reach $40B in the next five years and new technologies are on the rise. Thankfully, big data is providing new insights into prevention and treatments for breast and pelvic health. But a major factor in market growth is the rising incidence of female-specific diseases and disorders worldwide — from osteoporosis and osteoarthritis to anemia and hormonal imbalances,” said Krista Armstrong, Ph.D., Senior Vice President, Clinical Development Services, Premier Research.
“Integrating Health Decisions’ expertise in women’s health and diagnostic studies is a perfect complement to our CRO and consulting services for biotech and device sponsors, particularly in oncology, analgesia, and neuroscience. We can help customers seize this unprecedented moment in the women’s health market with our broad and differentiated services — from expert regulatory strategy to global clinical trial management, to the transparency and ease of the PremierOne Ecosystem that aggregates and coordinates administrative, financial, and patient data,” Armstrong added.
“The women’s health market has seen considerable investment and expansion across all key aspects, including Femtech in the last five years. In addition, the market opportunity in fluid-based diagnostics, specifically in oncology, infectious disease, and women’s health is supporting unprecedented levels of research in these areas. This collaboration gives sponsors the benefit of our deep understanding of female-centric trials and diagnostics coupled with Premier Research’s strong global footprint and expanded service capabilities. Sponsors will now have access to best-in-class holistic solutions in both of these areas,” said Dr. Patrick Phillips, CEO, Health Decisions. “Together, we look forward to bringing great value to drug developers and others seeking to help improve healthcare outcomes for women worldwide.”
Health Decisions has a dual focus on women’s health research and diagnostics and is supported by a network of 500 women’s health sites. Since 1989 the company has conducted more than 300 clinical trials, including more than 200 studies in women’s health indications such as reproductive and sexual health, menopause, pain management, osteoporosis, osteoarthritis, and gynecologic oncology. It has also delivered multiple PMAs and 510(k)s for IVD-focused sponsors that include successful submissions in high-risk HPV, colorectal cancer, and pre-term birth, amongst others.