Women‘s Health

Conduct of clinical trials with special female populations

CRS has special expertise in performing early phase clinical trials in the field of women’s health involving, in particular, women of childbearing potential, surgically sterilized or post-menopausal women. This specifically includes first-in-human (FIH) and long-term outpatient studies with challenging pharmacokinetic (PK)/ pharmacodynamic (PD) designs as well as early clinical trials with special populations, such as tubal ligated women.

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.

  • Common gynecological examination
  • Transvaginal ultrasound (TVUS)
  • Follicular growth and ovulation determined by transvaginal ultrasound (TVUS) as well as by hormone concentrations
  • Vaginal cytology
  • Endometrial biopsy
  • Insler and Hoogland Score

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BACK TO OVERVIEW

CRO Leadership Awards 2019

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

European Biotechnology Guide

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

EcoVadis – CSR Rating

Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.