souseikai global clinical research center

Female Studies

With advanced improvements in clinical research and development that safely and effectively treat mixed populations comes the need to better understand the differences between the populations themselves. Regarding sex and gender differences, the female study population needs to be properly represented from the early phases of drug development to determine if there are any relevant sex differences in disease therapy, especially for treatments specifically targeted for the female population.

Understanding BOTH the differences in disease prevalence and response for the female population and population as a whole is critical to the current and future safe development of advanced medical therapies. Our foresight regarding these developing trends and needs for clinical research led to the addition of experienced gynecologists to our team, as well as establishing diverse female study panels to address and anticipate growing needs.




THE FACTS

Since 2011, thanks to the depth of experience of our board certified OB/GYNs, we have safely and efficiently conducted 65 gynecological studies at SOUSEIKAI Global Clinical Research Center. These studies include 27 healthy young female studies ranging in age from 20-54 years old with cohorts from 5-54 subjects in size (dosing days are adjusted by menstrual cycle, e.g. follicular phase/luteal phase), and 38 healthy post-menopausal female studies ranging in age from 45-70 years old with cohorts from 16-132 subjects in size.


All gynecological exams are done by our in-house board certified gynecologists for procedures such as transvaginal sonography, echo mammography, and cytological exam.

PK/PD EVALUATIONS

EQUIPMENT