Conduct of clinical trials with special female populations
CRS gynecologists contribute considerable experience from practice
CRS´s gynecological group of peers consists of seven board-certified gynecologists working in different fields of gynecology with considerable experience from practice. They are contracted to CRS and available on demand to perform all gynecological examinations required, specified by protocol of any clinical trial.
Additionally, CRS has established a close collaboration with field-based gynecologists, which allows a powerful recruitment of trial participants from special patient populations such as, e.g., patients with endometriosis or polycystic ovary syndrome (PCOS).
The medical director is board-certified, both, as an anesthesiologist and as a clinical pharmacologist. A team of trained physicians is available for medical surveillance of all patients involved in clinical trials and CRS´s medical staff is also available to perform all study procedures.
In recent years, clinical trials with post-menopausal women have been performed on both, inpatients and outpatients. Handling and recruiting post-menopausal women is part of CRS’s standard routine; this is generally true for elderly volunteers.
Outpatient studies with women of childbearing potential can be conducted on a cycle dependent basis or with a synchronizing cycle intervention preceding the treatment phase, leading to larger subgroups and to more grouped treatment schedules.