Heavy menstrual bleeding (HMB) is one of the most common gynecologic disorders among women of reproductive age, accounting for up to one-third of all gynecologic office visits.1 HMB refers to bleeding associated with regular ovulatory cycles and involves blood loss...
Premier Research
Oncology & Hematology
Maximizing Oncology Study Outcomes: Protocol Development Considerations
Minimizing the burden that trial participants experience is essential for successful recruitment and retention, especially in oncology studies, where patients may need to be followed for years after the treatment phase of the trial. For sponsors, the process of optimizing...
During the initial planning for clinical trial implementation, intense focus is placed on strategies for patient recruitment, while strategies for patient engagement and retention are often left until after the treatment phase. However, with many current protocol designs in oncology,...
As we noted in a separate blog post, the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed...
One of Premier Research's differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Informed by today’s competitive drug development landscape, as well as by...
Women's Health
Addressing Research for Women from Every Angle
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...
Women's Health
Designing Trials for Patients
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...
Sponsors developing biologics must manage numerous scientific considerations specific to large-molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance. Clinical trials of biologics are designed to determine pharmacokinetics (PK),...
The development of biologics represents a major advancement, enabling the treatment of patients with many illnesses for which no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large-molecule products, including biochemical characterization...