Women’s Health Clinical Trial Expertise

The expertise to advance women’s health research globally

Historically, clinical trials have failed to adequately address the safety and efficacy concerns of women, and data shows that nearly half of health burdens are due to conditions that disproportionately affect women. With growing evidence of the risks this presents, it is obvious that successful research must be routed in a deep understanding of the unique needs of women. 

Supported by therapeutically-aligned strategist and operational experts plus a global network of thousands of highly experienced women’s health sites, Premier Research conquers the complexities of developing novel therapeutics and diagnostics for conditions that exclusively or disproportionately affect women. 

A collaborative & women-centric approach 

Women’s Health goes beyond indications that impact only women. We infuse a women-centric approach within our strategy whenever warranted by the target indication and patient population. Led by medical experts dedicated to women’s health, we bring together a diverse panel of therapeutic and functional specialists to optimize study design and accelerate research. 

Our experience

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Why choose Premier

• Expertise in women’s health research honed through more than 125 trials over the past five years, with a 30-year dedication to advancing women’s health research 
• Optimized site selection leveraging a network of thousands of women’s health sites to drive rapid start-up, improve patient engagement, and ensure data consistency 
• Proven track record working with multiple FDA divisions, including significant experience working with the Division of Urology and Obstetrics and Gynecology (DUOG) and Center for Devices and Radiological Health 
• Chosen CRO partner of the National Institute for Child Health Development Contraceptive Network (NICHD) program since its inception in 1996 
• Full suite of early development solutions, including global regulatory experts and commercial strategist offering strategic direction to enhance clinical trial performance 
• Customized and scalable medical device and diagnostics development solutions to support a variety of asset types across women’s health  

Therapeutic expertise

Complete lifecycle support 

The journey from concept to market is long. We’ll be with you every step of the way. From early discovery through commercialization, Premier has experts that provide tactical solutions to overcome nonclinical, preclinical, clinical, and commercial challenges at every stage. As a comprehensive development partner, we will help you advance from phase to phase, milestone to milestone. We collaborate with you to design and implement comprehensive study plans, with the flexibility to jump in at any point in your regulatory and product development journey.  

Key capabilities 

• Study design 
• Regulatory strategy 
• Study execution Submission Preparation 
• Submission Filing 
• Commercial Strategy