Obstetrics, Gynecology, and Urology
When conducting clinical trials for therapeutic agents or medical devices for obstetrics and gynecology (OB-GYN), proper study design and protocol are essential. Studies in OB-GYN typically include female reproductive health/infertility, dysmenorrhea, menopause, contraception, pelvic pain, and more.
There is much room in OB-GYN for expanded research efforts to enhance our understanding of the female reproductive process, which is essential to improving women’s health and reduce mortality. In particular, there is a strong need for the development of new contraceptive options. In fact, because of the side effects, adverse events, or lack of spontaneity that can be associated with available contraceptive methods, approximately 40% of women are not satisfied with their current contraceptive method. Yet each newly developed and approved contraceptive method is likely to allow every woman to find a method that meets her needs.
There is also much room for development in the field of urology. Clinical trials within this therapeutic area present their own set of challenges that require unique expertise. Studies in urology include male infertility, stress incontinence, urinary incontinence, and more.
When working Clinipace and our unified technology platform, TEMPO™, we can help to address the unique challenges within OB-GYN and urology trials, including appropriate trial enrollment, compliance, and monitoring. TEMPO allows for protocol and patient profile data in addition to data from all sites to be stored and accessed in a central database that is updated in real time, enabling visibility across the entire trial lifecycle, increasing data quality, and facilitating proactive, informed decisions about the research.
We can also guide you through a risk-based approach to monitoring (RBM), which applies a systematic process to the trial lifecycle components (designing, conducting, evaluating, and reporting the trial) that helps prevent or mitigate important and likely risks to data quality and participants. In this way, RBM places a focus on quality metrics, including enrollment and data completeness, among others.
In the end, we work to provide you with a more efficient and affordable program that minimizes data integration, reduces project startup costs, and empowers stakeholders to make informed data-driven decisions about your trials in OB-GYN and urology.